BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE RELOADABLE LINEAR CUTTER WITH SAFETY LOCK-OUT

    MDR report key: 1003626 · Received February 15, 2008

    Report

    Report Number
    1527736-2008-00928
    Event Type
    Malfunction
    Date Received
    February 15, 2008
    Date of Event
    January 17, 2008
    Report Date
    January 23, 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
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A COLECTOMY PROCEDURE THAT THE DEVICE WOULD CUT BUT STAPLED PARTIALLY. DEVICE STAPLED ONLY EVERY 2ND STAPLE. ANOTHER LIKE DEVICE WAS USED. THERE WAS NO PATIENT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROXIMATE RELOADABLE LINEAR CUTTER WITH SAFETY LOCK-OUT GDW ETHICON ENDO-SURGERY, INC. (CINCINNATI) NA D4HN14

    Patients

    Seq Age Sex Outcome Treatment
    1