BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH** ETS45 ENDOSCOPIC LINEAR CUTTER

    MDR report key: 2183054 · Received July 28, 2011

    Report

    Report Number
    3005075853-2011-03087
    Event Type
    Malfunction
    Date Received
    July 28, 2011
    Report Date
    July 7, 2011
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K020779
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). FIRING TRIGGER TEETH; FIRING POST. THE ANALYSIS RESULTS FOUND THAT THE ETS45 DEVICE WAS RETURNED WITH THE FIRING MECHANISM DAMAGED AND WITH NO RELOAD PRESENT. NO FUNCTIONAL TEST COULD BE PERFORMED DUE TO THE CONDITION OF THE DEVICE. THE DEVICE WAS DISASSEMBLED TO VERIFY THE CONDITION OF THE INTERNAL COMPONENTS; THE FIRING TRIGGER TEETH AND THE TRIGGER POST WERE FOUND BROKEN. WHILE NO CONCLUSION COULD BE REACHED OF WHAT CAUSE THE FIRING MECHANISM TO FAIL, IT IS POSSIBLE THAT THE DEVICE WAS FIRED ON TISSUE THICKER THAN INDICATED OR THROUGH A LOCKED CARTRIDGE. WHEN EITHER OR BOTH OF THESE SCENARIOS OCCUR, THE COMPONENTS IN THE FIRING MECHANISM CAN BE DAMAGED. IT SHOULD BE NOTED THAT A 100% INSPECTION TAKES PLACE DURING MANUFACTURING TO ENSURE THE DEVICE MEETS THE REQUIRE SPECIFICATIONS; (B)(4). NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE REPORTED INCIDENT, AS THERE WAS NO RELOAD RETURNED FOR ANALYSIS. EVENT COULD NOT BE CONFIRMED AS THE DEVICE WAS RETURNED WITH THE KNIFE COMPLETELY BACK.

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE AFFILIATE THAT DURING AN APPENDECTOMY PROCEDURE, THE KNIFE DID NOT MOVE BACK, NO FURTHER INFORMATION WAS AVAILABLE. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT. ADDITIONAL INFORMATION: IT IS UNCLEAR WHEN THE KNIFE "SHOWED UP". THE SURGEON FIRED, OPENED THE INSTRUMENT AND NOTHING WAS TO BE SEEN ON THE APPENDIX, NO STAPLES, NO CUT. THE SURGEON REMOVED THE INSTRUMENT VIA TROCAR AND THEN THE NURSE SAW THE KNIFE, NO ONE CAN SAY HOW PULLED/FIRED ETC. THEY TOOK A NEW INSTRUMENT AND THE SURGERY WAS FINALISED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH** ETS45 ENDOSCOPIC LINEAR CUTTER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK NI

    Patients

    Seq Age Sex Outcome Treatment
    1 RELOAD: (B)(4)