BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 1253021 · Received December 9, 2008

    Report

    Report Number
    1527736-2008-03477
    Event Type
    Malfunction
    Date Received
    December 9, 2008
    Date of Event
    May 7, 2008
    Report Date
    May 8, 2008
    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

    DAMAGED FIRING TRIGGER TEETH.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNK PROCEDURE, THE DEVICE COULD NOT BE FIRED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH ETS FLEX-45 ENDOSCOPIC ARTICULATING LINEAR CUTTER, 45 MM STAPLE LINE-4. NONE GDW ETHICON ENDO SURGERY, INC. (CINCINNATI) NA D4H325

    Patients

    Seq Age Sex Outcome Treatment
    1