BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE** SKIN STAPLER 35 WIDE

    MDR report key: 2112381 · Received June 3, 2011

    Report

    Report Number
    3005075853-2011-02273
    Event Type
    Malfunction
    Date Received
    June 3, 2011
    Date of Event
    May 13, 2011
    Report Date
    May 16, 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
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). (DEVICE B): METHOD/RESULTS/CONCLUSIONS: DEVICE (A) WAS RETURNED IN GOOD VISUAL CONDITION AND FULLY FUNCTIONAL. WHEN TESTED FOR FUNCTIONALITY, THE DEVICE FIRED AND FORMED THE REMAINING 31 STAPLES AS INTENDED. THE DEVICE FIRED WITHOUT ANY DIFFICULTIES AND THE STAPLES WERE NOTE TO HAVE THE PROPER BOX SHAPE. DEVICE (B) WAS RECEIVED STERILE AND IN GOOD VISUAL CONDITION. THE DEVICE WAS TESTED FOR FUNCTIONALITY; THE DEVICE FIRED AND FORMED THE STAPLES AS INTENDED. THE DEVICE FIRED WITHOUT ANY DIFFICULTIES AND THE STAPLES WERE NOTE TO HAVE THE PROPER BOX SHAPE. THE BATCH RECORDS WERE REVIEWED AND THE FINAL QUALITY RELEASE CRITERIA WERE MET BEFORE THE BATCHES WERE RELEASED FOR DISTRIBUTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE STAPLES WERE NOT CLOSING PROPERLY WHEN THE DEVICE WAS FIRED. ANOTHER DEVICE WAS USED IN WHICH THE SAME ISSUE WAS NOTICED. A THIRD DEVICE FROM A DIFFERENT LOT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT. ONE OF THE USED DEVICES WAS DISCARDED BUT A STERILE DEVICE FROM THE SAME LOT WILL BE RETURNED.

    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 H43E21

    Patients

    Seq Age Sex Outcome Treatment
    1