BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH ETS FLEX45 ENDOSCOPIC ARTICULATING LINEAR CUTTER, 45 MM STAPLE LINE-2.5

    MDR report key: 1823816 · Received December 12, 2007

    Report

    Report Number
    1527736-2007-08447
    Event Type
    Malfunction
    Date Received
    December 12, 2007
    Report Date
    November 20, 2007
    Manufacturer
    ETHICON ENDO SURGERY, INC (CINCINNATI)
    Product Code
    GDW
    PMA / PMN Number
    K020779
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL SUMMARY - THE ANALYSIS RESULTS FOUND THAT THE DEVICE WAS RETURNED WITH THE CLAMPING MECHANISM DAMAGED AND WITH NO CARTRIDGE PRESENT. THE DEVICE WAS DISASSEMBLED TO VERIFY THE CONDITION OF THE INTERNAL COMPONENTS AND THE FIRING TRIGGER TEETH AND THE TRIGGERS POST WERE FOUND BROKEN, NO FUNCTIONAL TEST WAS PERFORMED. IT SHOULD BE NOTED THAT A 100% INSPECTIONS TAKES PLACE DURING MFG TO ENSURE THE DEVICE MEETS THE REQUIRED SPECIFICATION. THE MFG RECORDS WERE REVIEWED AND NO ANOMALIES WERE FOUND DURING THE MFG PROCESS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTS THAT DURING A PROCEDURE, THE DEVICE WAS MISFIRING. THE STAPLES DID NOT COME OUT, NO CUTTING. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT CONSEQUENCE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH ETS FLEX45 ENDOSCOPIC ARTICULATING LINEAR CUTTER, 45 MM STAPLE LINE-2.5 GDW ETHICON ENDO SURGERY, INC (CINCINNATI) NA D4J944

    Patients

    Seq Age Sex Outcome Treatment
    1