BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE RH ROTATING HEAD SKIN STAPLER

    MDR report key: 1121927 · Received August 13, 2008

    Report

    Report Number
    3005075853-2008-01171
    Event Type
    Malfunction
    Date Received
    August 13, 2008
    Date of Event
    June 27, 2008
    Report Date
    July 29, 2008
    Manufacturer
    ETHICON ENDO-SURGERY, LLC
    Product Code
    GDT
    PMA / PMN Number
    K833357
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT: 08/13/2008. INFO ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE DEVICES WERE NOT WORKING. IT APPEARS THAT THE STAPLES CAME OUT SIDE WAYS AND NOT FORMED. THE CASE WAS COMPLETED WITH ANOTHER DEVICE. THERE WERE NO PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROXIMATE RH ROTATING HEAD SKIN STAPLER GDT ETHICON ENDO-SURGERY, LLC NA E4KT26

    Patients

    Seq Age Sex Outcome Treatment
    1