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  "name": "The Everest Bipolar Cutting Forceps are intended to be passed through a 5-mm or 10-mm cannula, depending on the model/outer diameter size of the forceps.  Coagulation is achieved using electrosurgical energy under visualization.  The device is to be used with bipolar outputs of compatible generators.  The forceps' jaws are electrically isolated from each other enabling one jaw to act as a return electrode, eliminating the need for a return pad.  To transect tissue, a cutting blade is actuated and moves between the electrode jaws.        The connections (bipolar electrical signal) to the forceps are through either a hardwired cable (model 3006) or a connector at the bottom of the handle (models 3000 and 3005).  The device includes mechanisms (switches and triggers) to provide coagulation using the bipolar electrical energy that reaches the forceps.  The forceps are positioned in the desired location for grasping, coagulation, and transection of tissue.  The anatomical structure to be coagulated is placed between the open forceps jaws, and once the Forceps Grip trigger is squeezed, the forceps' jaws are closed onto tissue, followed by coagulation.  The device includes a blade that is mechanically advanced to perform tissue cutting as needed.",
  "description": "FDA recall Z-2542-2024 — Olympus Corporation of the Americas is recalling The Everest Bipolar Cutting Forceps are intended to be passed through a 5-mm or 10-mm cannula, depending on the model/outer diameter size of the forceps.  Coagulation is achieved using electrosurgical energy under visualization.  The device is to be used with bipolar outputs of compatible generators.  The forceps' jaws are electrically isolated from each other enabling one jaw to act as a return electrode, eliminating the need for a return pad.  To transect tissue, a cutting blade is actuated and moves between the electrode jaws.        The connections (bipolar electrical signal) to the forceps are through either a hardwired cable (model 3006) or a connector at the bottom of the handle (models 3000 and 3005).  The device includes mechanisms (switches and triggers) to provide coagulation using the bipolar electrical energy that reaches the forceps.  The forceps are positioned in the desired location for grasping, coagulation, and transection of tissue.  The anatomical structure to be coagulated is placed between the open forceps jaws, and once the Forceps Grip trigger is squeezed, the forceps' jaws are closed onto tissue, followed by coagulation.  The device includes a blade that is mechanically advanced to perform tissue cutting as needed. (Devices, Class II). The enforcement record is RECORDED; the classification is a DETERMINATION (FDA's regulatory verdict); the boundary is INTERPRETATION (a recall ≠ harm to a specific person). Source: openFDA. CC0.",
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  "dateModified": "2026-06-24T07:02:03.626072+00:00",
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    "name": "The Everest Bipolar Cutting Forceps are intended to be passed through a 5-mm or 10-mm cannula, depending on the model/outer diameter size of the forceps.  Coagulation is achieved using electrosurgical energy under visualization.  The device is to be used with bipolar outputs of compatible generators.  The forceps' jaws are electrically isolated from each other enabling one jaw to act as a return electrode, eliminating the need for a return pad.  To transect tissue, a cutting blade is actuated and moves between the electrode jaws.        The connections (bipolar electrical signal) to the forceps are through either a hardwired cable (model 3006) or a connector at the bottom of the handle (models 3000 and 3005).  The device includes mechanisms (switches and triggers) to provide coagulation using the bipolar electrical energy that reaches the forceps.  The forceps are positioned in the desired location for grasping, coagulation, and transection of tissue.  The anatomical structure to be coagulated is placed between the open forceps jaws, and once the Forceps Grip trigger is squeezed, the forceps' jaws are closed onto tissue, followed by coagulation.  The device includes a blade that is mechanically advanced to perform tissue cutting as needed.",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "Olympus Corporation of the Americas"
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      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2542-2024/enforcement-record",
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      "name": "FDA recall Z-2542-2024: Olympus Corporation of the Americas is recalling The Everest Bipolar Cutting Forceps are intended to be passed through a 5-mm or 10-mm cannula, depending on the model/outer diameter size of the forceps.  Coagulation is achieved using electrosurgical energy under visualization.  The device is to be used with bipolar outputs of compatible generators.  The forceps' jaws are electrically isolated from each other enabling one jaw to act as a return electrode, eliminating the need for a return pad.  To transect tissue, a cutting blade is actuated and moves between the electrode jaws.        The connections (bipolar electrical signal) to the forceps are through either a hardwired cable (model 3006) or a connector at the bottom of the handle (models 3000 and 3005).  The device includes mechanisms (switches and triggers) to provide coagulation using the bipolar electrical energy that reaches the forceps.  The forceps are positioned in the desired location for grasping, coagulation, and transection of tissue.  The anatomical structure to be coagulated is placed between the open forceps jaws, and once the Forceps Grip trigger is squeezed, the forceps' jaws are closed onto tissue, followed by coagulation.  The device includes a blade that is mechanically advanced to perform tissue cutting as needed.",
      "text": "The FDA logged enforcement record Z-2542-2024: Olympus Corporation of the Americas is voluntarily recalling The Everest Bipolar Cutting Forceps are intended to be passed through a 5-mm or 10-mm cannula, depending on the model/outer diameter size of the forceps.  Coagulation is achieved using electrosurgical energy under visualization.  The device is to be used with bipolar outputs of compatible generators.  The forceps' jaws are electrically isolated from each other enabling one jaw to act as a return electrode, eliminating the need for a return pad.  To transect tissue, a cutting blade is actuated and moves between the electrode jaws.        The connections (bipolar electrical signal) to the forceps are through either a hardwired cable (model 3006) or a connector at the bottom of the handle (models 3000 and 3005).  The device includes mechanisms (switches and triggers) to provide coagulation using the bipolar electrical energy that reaches the forceps.  The forceps are positioned in the desired location for grasping, coagulation, and transection of tissue.  The anatomical structure to be coagulated is placed between the open forceps jaws, and once the Forceps Grip trigger is squeezed, the forceps' jaws are closed onto tissue, followed by coagulation.  The device includes a blade that is mechanically advanced to perform tissue cutting as needed. — reason: Fractures and breakages in packaging trays and Tyvek covers, which may result in a sterility breach. Status: Ongoing — the recall is still being carried out.. Initiated 2024-07-01. Affected lots/codes: UDI: 00821925035898 Batch Number: FR145210  FR150478  FR163740  FR165213  FR177466  FR179534  FR179557  FR188129  FR200177  FR215047  FR220528  FR220979  FR224466  FR234887  FR248322  FR253501  FR255664  FR263141  FR269277  FR276180  FR287091  FR303624  FR305537  FR316877  FR378738  FR388883  PW308633  PW308686  PW308722  PW308723. A RECORDED FDA enforcement action (occurred=true).",
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        "value": "Devices recall, status Ongoing",
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      "falsifier": "A RECORD of measured/reported events (occurred=true) from openFDA drug & device enforcement (recall) reports — U.S. FDA; superseded when openFDA drug & device enforcement (recall) reports — U.S. FDA publishes its next release."
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      "name": "FDA classified recall Z-2542-2024 as Class II",
      "text": "The FDA assigned this recall Class II: Class II — the FDA judged the product may cause temporary or medically reversible harm, with a remote chance of serious harm.. This is the FDA's official risk classification — its regulatory DETERMINATION of the hazard category (a verdict constituted by the FDA's recognition, occurred=FALSE), adjudged=TRUE because the FDA issued it. It is NOT a measurement of harm to any specific person.",
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      "falsifier": "occurred=FALSE: a regulatory DETERMINATION (an authority's classification/judgment) has NO material truthmaker independent of recognition — it is constituted by U.S. FDA recall classification (openFDA enforcement)'s say-so (a Searle institutional fact), not measured. adjudged=TRUE because U.S. FDA recall classification (openFDA enforcement) (an external authority) issued it. Distinct from a recorded measurement (which has an independent truthmaker) and from a modeled figure (a computed quantity, not a verdict). Challengeable; superseded if the authority reclassifies."
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      "@type": "schema:Claim",
      "name": "What an FDA recall is — and is NOT",
      "text": "A recall is a RECORDED FDA enforcement action — the FDA logged that a firm is removing or correcting a product, classed by the FDA's risk judgment. It does NOT establish that any specific unit is affected or caused harm; causation is not established. This record informs and compares — it is NOT medical advice and does not tell anyone to start or stop a drug or device. For a medical decision, route to the FDA recall record and a licensed pharmacist or prescriber.",
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      "falsifier": "occurred=FALSE (a framing, not an event) and adjudged=FALSE (an in-house reading, not an authority's verdict) — the LOWEST-warrant claim here. A flat representation would render this identically to the official facts; the four-status does not."
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            "Value": "Fractures and breakages in packaging trays and Tyvek covers, which may result in a sterility breach",
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            "Value": "UDI: 00821925035898 Batch Number: FR145210  FR150478  FR163740  FR165213  FR177466  FR179534  FR179557  FR188129  FR200177  FR215047  FR220528  FR220979  FR224466  FR234887  FR248322  FR253501  FR255664  FR263141  FR269277  FR276180  FR287091  FR303624  FR305537  FR316877  FR378738  FR388883  PW308633  PW308686  PW308722  PW308723",
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            "Field": "Distribution pattern",
            "Value": "Worldwide distribution - US Nationwide and the countries of CA, DE, AU, SG, KR.",
            "Status": "recorded"
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