BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE** SKIN STAPLER 35 WIDE

    MDR report key: 2031978 · Received March 28, 2011

    Report

    Report Number
    3005075853-2011-01228
    Event Type
    Malfunction
    Date Received
    March 28, 2011
    Date of Event
    March 3, 2011
    Report Date
    March 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
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NONCONFORMING STAPLE STACK. THE ANALYSIS RESULTS SHOWED THAT THE INSTRUMENT WAS RETURNED NON- FUNCTIONAL DUE TO A NON-CONFORMING STAPLE STACK. IN ADDITION, TWO STAPLES WERE FOUND JAMMED IN THE CARTRIDGE NOSE. WHEN THE STAPLE STACK IS FOUND TO BE NONCONFORMING, STAPLES WILL BECOME JAMMED IN THE CARTRIDGE, NOT ALLOWING THE STAPLES TO PROPERLY ADVANCE AND POSSIBLY PREVENTING THE DEVICE FROM FIRING. THE STAPLES WERE REMOVED AND THE STAPLE STACK BECAME ALIGNED. THE DEVICE WAS TESTED FOR FUNCTIONALITY AND IT FIRED AND FORMED THE REMAINING 15 STAPLES AS INTENDED. THE DEVICE FIRED WITHOUT ANY DIFFICULTIES AND THE STAPLES WERE NOTED TO HAVE THE PROPER BOX SHAPE. WHILE NO CONCLUSION COULD BE REACHED AS TO HOW THE STAPLE STACK BECAME MISALIGNED, IT SHOULD BE NOTED THAT AS PART OF OUR QUALITY PROCESS, EACH DEVICE IS VISUALLY INSPECTED AND FUNCTIONALLY TESTED DURING MANUFACTURING TO ENSURE THAT THE DEVICE MEETS THE REQUIRED SPECIFICATIONS PRIOR TO SHIPMENT. 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 A KNEE REPLACEMENT PROCEDURE, THE DEVICE WAS PRODUCING MALFORMED STAPLES ON UNKNOWN FIRINGS. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT.

    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 H4330M

    Patients

    Seq Age Sex Outcome Treatment
    1