BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH ETS45

    MDR report key: 1823303 · Received August 30, 2010

    Report

    Report Number
    3005075853-2010-04904
    Event Type
    Malfunction
    Date Received
    August 30, 2010
    Date of Event
    July 6, 2010
    Report Date
    August 3, 2010
    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
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFO ANTICIPATED, BUT UNAVAILABLE AT THIS TIME. FIRING TRIGGER TEETH. EVAL SUMMARY: THE ANALYSIS RESULTS FOUND THAT THE (B)(4) DEVICE WAS RETURNED WITH THE FIRING MECHANISM DAMAGED AND 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 AND THE FIRING TRIGGER TEETH WERE FOUND BROKEN. WHILE NO CONCLUSION COULD BE REACH 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. THE DEVICE OPENED AND CLOSED AS INTENDED. IT SHOULD BE NOTED THAT A 100% INSPECTION TAKES PLACE DURING MANUFACTURING TO ENSURE THE DEVICE MEETS THE REQUIRE SPECIFICATIONS; IN ADDITION, A SAMPLE OF THE BATCH IS INSPECTED AT (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC SIGMOID PROCEDURE, THE JAWS OF THE INSTRUMENT DID NOT OPEN DURING THE LAPAROSCOPIC PROCEDURE. THE INSTRUMENT WAS ALREADY IN THE BODY. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCE FOR THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH ETS45 GDW STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC NA G4RR4U

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK