BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE** SKIN STAPLER 35 REGULAR

    MDR report key: 2180314 · Received July 27, 2011

    Report

    Report Number
    3005075853-2011-03031
    Event Type
    Malfunction
    Date Received
    July 27, 2011
    Date of Event
    June 27, 2011
    Report Date
    June 28, 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). DEVICES B AND C: (B)(4). DEVICE (A) WAS RETURNED IN GOOD VISUAL CONDITION AND FULLY FUNCTIONAL. ADDITIONALLY, ONE FORMED AND ONE UNFORMED STAPLE WERE RECEIVED INSIDE A SMALL BAG. 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 NOTED TO HAVE THE PROPER BOX SHAPE. DEVICE B AND C WERE RETURNED STERILE, IN GOOD VISUAL CONDITION AND FULLY FUNCTIONAL. WHEN TESTED FOR FUNCTIONALITY, THE DEVICES FIRED AND FORMED ALL THE STAPLES AS INTENDED. THE DEVICES FIRED WITHOUT ANY DIFFICULTIES AND THE STAPLES WERE NOTED TO HAVE THE PROPER BOX SHAPE. A BATCH RECORD REVIEW WAS PERFORMED AND NO ANOMALIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN USE OF THREE DEVICES IN THE ER FOR ONE EVENT, THE STAPLES DID NOT FORM ON ALL THREE DEVICES. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE WITH NO PATIENT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROXIMATE** SKIN STAPLER 35 REGULAR SKIN STAPLER GDT ETHICON ENDO-SURGERY, LLC. NA H43Z3M

    Patients

    Seq Age Sex Outcome Treatment
    1