BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH ETS FLEX45 ENDOSCOPIC ARTICULATING LINEAR CUTTER, 45 MM STAPLE LINE - 4

    MDR report key: 1823765 · Received December 13, 2007

    Report

    Report Number
    1527736-2007-08475
    Event Type
    Malfunction
    Date Received
    December 13, 2007
    Date of Event
    November 7, 2007
    Report Date
    November 26, 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
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE ANALYSIS SHOWED THAT THE DEVICE WAS RECEIVED IN GOOD VISUAL CONDITION AND WITH NO CARTRIDGE PRESENT. THE RETURNED DEVICE WAS FOUND TO BE NON FUNCTIONAL AS THE RELEASE BUTTON WAS NOTED TO BE DAMAGED. THE DEVICE WAS DISASSEMBLED TO VERIFY THE CONDITION OF THE INTERNAL COMPONENTS AND THE RELEASE BUTTON WAS FOUND BROKEN, IN ADDITION THE FIRING TRIGGER TEETH WERE FOUND TO BE BROKEN. NO FUNCTIONAL TEST COULD BE PERFORMED DUE TO THE CONDITION OF THE DEVICE. THE MANUFACTURING RECORDS WERE REVIEWED AND NO ANOMALIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNK PROCEDURE, THERE WERE NO CUTTING AND STAPLES AFTER FIRING. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE PT WAS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH ETS FLEX45 ENDOSCOPIC ARTICULATING LINEAR CUTTER, 45 MM STAPLE LINE - 4 GDW ETHICON ENDO SURGERY, INC (CINCINNATI) NA D4H69H

    Patients

    Seq Age Sex Outcome Treatment
    1