BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE ILS CURVED CIR

    MDR report key: 1822664 · Received November 27, 2007

    Report

    Report Number
    1527736-2007-07924
    Event Type
    Malfunction
    Date Received
    November 27, 2007
    Date of Event
    October 23, 2007
    Report Date
    November 2, 2007
    Manufacturer
    ETHICON ENDO-SURGERY, INC. (CINCINNATI)
    Product Code
    GDW
    PMA / PMN Number
    K983536
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNK PROCEDURE, THE DEVICE WOULD NOT STAPLE AND WOULD NOT CUT. COMPLETED WITH THE SAME LIKE PRODUCT. THERE WAS NO PT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROXIMATE ILS CURVED CIR GDW ETHICON ENDO-SURGERY, INC. (CINCINNATI) NA D4GY6Z

    Patients

    Seq Age Sex Outcome Treatment
    1