BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 1831438 · Received December 17, 2007

    Report

    Report Number
    1527736-2007-08544
    Event Type
    Malfunction
    Date Received
    December 17, 2007
    Date of Event
    December 5, 2007
    Report Date
    December 6, 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
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DIAGNOSTIC GYN PROCEDURE THERE WERE MALFORMED (PEAR SHAPED) STAPLES. SURGEON USED THIS DEVICE WITH A SECOND RELOAD AND COMPLETED THE CASE. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1