BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETS FLEX ARTICNG LNR CUTR 45MM

    MDR report key: 1130324 · Received August 20, 2008

    Report

    Report Number
    3005075853-2008-01291
    Event Type
    Malfunction
    Date Received
    August 20, 2008
    Date of Event
    July 16, 2008
    Report Date
    July 18, 2008
    Manufacturer
    ETHICON ENDO-SURGERY, LLC
    Product Code
    GDW
    PMA / PMN Number
    K020779
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FIRING TRIGGER TEETH. EVAL SUMMARY: TWO DEVICE (A-B) WERE RETURNED FOR ANALYSIS. DEVICE A WAS RECEIVED IN GOOD VISUAL CONDITION AND WITH A RELOAD IN THE DEVICE. THE RELOAD WAS RECEIVED PARTIALLY FIRED AND WITH THE CARTRIDGE LOCK OUT TAB BENT. THE DAMAGE TO THE RELOAD LOCKOUT TAB IS CONSISTENT WITH DAMAGE OBSERVED WHEN THE FIRING CYCLE IS STARTED, INTERRUPTED, RELEASED, AND RESTARTED. ONCE THE FIRING CYCLE HAS BEEN INITIATED, IT MUST BE COMPLETED. IF RE-INITIATION OF FIRING IS RESUMED, THE DEVICE WILL LOCKOUT. FIRING THROUGH THE LOCKOUT MECHANISM WILL BREAK THE DEVICE. DEVICE B WAS RECEIVED IN GOOD VISUAL CONDITION AND WITHOUT RELOAD PRESENT. THE DEVICE WAS NOTICED TO HAVE THE FIRING AND CLAMPING MECHANISMS DAMAGED, NO FUNCTIONAL TEST WAS PERFORMED DUR TO THE CONDITION OF THE DEVICE. THE DEVICE WAS DISASSEMBLED TO VERIFY THE CONDITION OF THE INTERNAL COMPONENTS AND YOKE TEETH WERE FOUND BROKEN. ALTHOUGH NO CONCLUSION COULD BE REACHED AS TO HOW THE YOKE TEETH BECAME BROKEN, THIS DAMAGE CAN OCCUR WHEN EXCESSIVE FORCE IS APPLIED TO THE CLOSING TRIGGER WHEN THE JAWS ARE CLAMPED ON TISSUE THICKER THAN INDICATED. A 100% INSPECTION TAKES PLACE DURING MFG TO ENSURE THE DEVICE MEETS THE REQUIRED SPEC PRIOR TO SHIPPING. THE MFG RECORDS WERE REVIEWED AND NO ANOMALIES WERE FOUND DURING THE MFG PROCESS. ADD'L INFO ON DEVICE B: BATCH# E5P33D. CONCLUSION: YOKE TEETH BROKEN.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE SALES REP., THAT THE DEVICES WERE DEFECTIVE. NO OTHER INFO WAS AVAILABLE. THERE WAS NO REPORTED PT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETS FLEX ARTICNG LNR CUTR 45MM GDW ETHICON ENDO-SURGERY, LLC NA E4L9N

    Patients

    Seq Age Sex Outcome Treatment
    1