BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENTOPATH ETS FLEX45 ENDOSCOPIC ARTICULATING LINEAR CUTTER, 45 MM STAPLE LINE - 2

    MDR report key: 1163338 · Received September 10, 2008

    Report

    Report Number
    3005075853-2008-01623
    Event Type
    Malfunction
    Date Received
    September 10, 2008
    Date of Event
    June 25, 2008
    Report Date
    July 2, 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 Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: THE ANALYSIS SHOWED THAT THE DEVICE WAS RECEIVED WITH THE HANDLES DAMAGED AND THE FIRING MECHANISM DAMAGED AND WITH A RELOAD IN THE DEVICE. THE RELOAD WAS RECEIVED PARTIALLY FIRED AND WITH NO DAMAGE TO THE RELOAD LOCK OUT SPRING. THE RETURNED DEVICE WAS FOUND TO BE NON FUNCTIONAL AS THE FIRING MECHANISM WAS NOTED TO BE DAMAGED. THE DEVICE WAS DISASSEMBLED TO VERIFY THE CONDITION OF THE INTERNAL COMPONENTS AND THE FIRING TRIGGER TEETH WERE FOUND DAMAGED. NO FUNCTIONAL TEST COULD BE PERFORMED DUE TO THE CONDITION OF THE DEVICE. IT SHOULD BE NOTED THAT A 100% INSPECTION TAKES PLACE DURING MFG TO ENSURE THE DEVICE MEETS THE REQUIRE SPECS; IN ADDITION, A SAMPLE OF THE BATCH IS INSPECTED AT FGQA. THE MFG RECORDS WERE REVIEWED AND NO ANOMALIES WERE FOUND DURING THE MFG PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNK PROCEDURE, THE DEVICE WOULD NOT STAPLE AND WOULD NOT CUT. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENTOPATH ETS FLEX45 ENDOSCOPIC ARTICULATING LINEAR CUTTER, 45 MM STAPLE LINE - 2 GDW ETHICON ENDO-SURGERY, LLC NA C4FU0C

    Patients

    Seq Age Sex Outcome Treatment
    1