BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP** ENDOSCOPIC CLIP APPLIER

    MDR report key: 3841352 · Received May 30, 2014

    Report

    Report Number
    3005075853-2014-03681
    Event Type
    Malfunction
    Date Received
    May 30, 2014
    Report Date
    April 1, 2014
    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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: YIELDED JAW. THE ANALYSIS RESULT SHOWED THAT THE ER320 INSTRUMENT WAS RECEIVED EMPTY AND 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. NO FUNCTIONAL TEST COULD BE PERFORMED DUE TO THE RETURNED CONDITION OF THE DEVICE. IT IS KNOWN FROM THE HISTORY OF THE DEVICE THAT THE CONDITION OF THE JAWS MAY LEAD DROPPING/EJECTED CLIPS. IN ADDITION, THE LOCKOUT FEATURE WAS NOTED TO BE NON FUNCTIONAL. IN ORDER TO EVALUATE THE CONDITION OF THE INTERNAL COMPONENTS OF THE DEVICE, IT WAS DISASSEMBLED. UPON DISASSEMBLING, THE LOCKOUT POSTS WERE FOUND TO BE BROKEN WHICH SUGGEST THAT A LOCKOUT PREMATURE OCCURRED. IT COULD NOT BE DETERMINED WHAT MAY HAVE CAUSED THIS FINDING. A BATCH RECORD REVIEW WAS PERFORMED AND NO ANOMALIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    THE SALES REP REPORTED THAT DURING AN UNKNOWN PROCEDURE THE DEVICE JAMMED, WOULD NOT FIRE. IT IS NOT KNOWN HOW THE CASE WAS COMPLETED. NO PATIENT CONSEQUENCES REPORTED. THERE WAS NO ADDITIONAL INFORMATION. ONE DEVICE WILL BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319343 LIGACLIP** ENDOSCOPIC CLIP APPLIER CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1