BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP** ENDOSCOPIC CLIP APPLIER

    MDR report key: 3031150 · Received April 2, 2013

    Report

    Report Number
    3005075853-2013-01552
    Event Type
    Malfunction
    Date Received
    April 2, 2013
    Date of Event
    March 7, 2013
    Report Date
    March 7, 2013
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    FZP
    PMA / PMN Number
    K864102
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE WAS NOT RETURNED FOR EVALUATION.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED FOR ANALYSIS AND UPON INSPECTION THE JAWS WERE FOUND TO BE IN A YIELDED CONDITION MAKING THE DEVICE NON-FUNCTIONAL. POSSIBLE CAUSES FOR THE CONDITION FOUND MAY BE IF THE DEVICE IS CLOSED OVER AN EXISTING HARD OBJECT OR CLIP PLACING STRESS ON THE JAWS CAUSING THEM TO DISTORT OR YIELD AND NOT RETURN TO THEIR ORIGINAL DIMENSIONS/POSITION OR EXCESSIVE APPLICATION OF TORQUE TO THE JAWS WHEN POSITIONING THE DEVICE ON A VESSEL. IT IS KNOWN FROM THE HISTORY OF THE DEVICE THAT THE CONDITION OF THE JAWS MAY LEAD DROPPING/EJECTED CLIPS. DUE TO THE CONDITION OF THE RETURNED DEVICE IT COULD NOT BE DETERMINED WHAT MAY HAVE CAUSED THE REPORTED EVENT. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PRODUCT SPECIALIST RECEIVED AN EMAIL ON (B)(6) 2013 REGARDING AN ISSUE ON THE DEVICE. CLIPS WERE FALLING OUT BEFORE BEING FIRED. NAME AND DATE OF THE PROCEDURE IS NOT KNOWN. PRODUCT SPECIALIST COULD NOT ASCERTAIN WHETHER IT HAD INVOLVED AN ADVERSE EVENT. NO INFORMATION WAS PROVIDED REGARDING ANY PATIENT DETAILS, DELAY IN THE PROCEDURE AND THE OUTCOME OF THE PROCEDURE. XRAYS AND PHOTOS ARE NOT AVAILABLE. DEVICE HAS BEEN DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134526 LIGACLIP** ENDOSCOPIC CLIP APPLIER CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1