BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX-5MM ENDO CLIP APPLIER

    MDR report key: 3052096 · Received April 11, 2013

    Report

    Report Number
    3005075853-2013-01716
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Report Date
    March 15, 2013
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    FZP
    PMA / PMN Number
    K050344
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PHOTOGRAPH SHOWS A TOTAL OF SIX CLIPS FIVE OF THE SIX APPEAR TO HAVE PROPER FORM. THE MALFORMED CLIP HOWEVER APPEARS TO HAVE A DIFFERENT ANGLE OF PLACEMENT RELATIVE TO THE OTHER FIVE. THE SUBJECT CLIP HAS A EXTREME CLIP LEG MISALIGNMENT. THE LEGS APPEAR TO HAVE SCISSORED WHILE STAYING IN PARALLEL PLANES. THE CAUSES OF CLIP SCISSORING TYPICALLY CAN BE ATTRIBUTED TO EXCESSIVE FORCES BEING APPLIED TO THE CLIP AND CLIP JAWS DURING FIRING, JAW ALIGNMENT ISSUES TYPICALLY FROM A PREVIOUS FIRING, OR CATCHING A HARD OBJECT LIKE A PREVIOUSLY PLACED CLIP BETWEEN THE JAWS.

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS RESULTS OF THE DEVICE FOUND THAT IT WAS RECEIVED WITH THE JAWS MISALIGNED. IN AN ATTEMPT TO REPLICATE THE REPORTED INCIDENT, THE DEVICE WAS TESTED FOR FUNCTIONALITY. UPON FIRING OF THE DEVICE, THE CLIPS WERE FED AS INTENDED; HOWEVER, DUE TO THE MISALIGNED CONDITION OF THE JAWS SCISSOR CLIPS WERE FORMED. 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. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, THE DEVICE MISFIRED AND THE CLIPS WERE SCISSORED. UNKNOWN HOW THE CASE WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156935 LIGAMAX-5MM ENDO CLIP APPLIER CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA K48946

    Patients

    Seq Age Sex Outcome Treatment
    1