BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE** SKIN STAPLER 35 WIDE

    MDR report key: 2221669 · Received August 24, 2011

    Report

    Report Number
    3005075853-2011-03482
    Event Type
    Malfunction
    Date Received
    August 24, 2011
    Date of Event
    July 28, 2011
    Report Date
    August 4, 2011
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDT
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS RESULTS CONFIRMED THAT THE DEVICE WAS RETURNED IN GOOD VISUAL CONDITION AND FULLY FUNCTIONAL. WHEN TESTED FOR FUNCTIONALITY THE DEVICE FIRED AND FORMED THE REMAINING 13 STAPLES AS INTENDED. THE DEVICE FIRED WITHOUT ANY DIFFICULTIES AND THE STAPLES WERE NOTE TO HAVE THE PROPER BOX SHAPE. THE FINAL QUALITY RELEASE CRITERIA WERE MET BEFORE THIS BATCH WAS RELEASED FOR DISTRIBUTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A TOTAL KNEE PROCEDURE, THE STAPLES WERE MALFORMED. ONLY ONE SIDE WOULD FORM. THEY ATTEMPTED TO USE ANOTHER STAPLER FROM THE SAME LOT NUMBER AND THE SAME THING OCCURRED. THEY OPENED ANOTHER STAPLER FROM A DIFFERENT LOT NUMBER AND USED IT SUCCESSFULLY. THERE WERE NO PATIENT CONSEQUENCES. ADDITIONAL INFORMATION: THIS SURGEON HAS USED THIS PRODUCT MANY TIMES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROXIMATE** SKIN STAPLER 35 WIDE SKIN STAPLER GDT ETHICON ENDO-SURGERY, LLC. NA H4400R

    Patients

    Seq Age Sex Outcome Treatment
    1