BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE** SKIN STAPLER 35 WIDE

    MDR report key: 1932760 · Received December 20, 2010

    Report

    Report Number
    3005075853-2010-07254
    Event Type
    Malfunction
    Date Received
    December 20, 2010
    Date of Event
    December 7, 2010
    Report Date
    December 9, 2010
    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
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NONCONFORMING CARTRIDGE WELD. THE ANALYSIS RESULTS CONFIRMED THAT THE DEVICE WAS RECEIVED IN GOOD VISUAL CONDITIONS. WHEN IT WAS TESTED FOR FUNCTIONALITY, THE STAPLES WERE EJECTED AND NOT HITTING THE ANVIL DUE TO AN INSUFFICIENT WELD. THE CARTRIDGE WELD IS DIRECTLY RELATED TO THE CARTRIDGE GAP. THE CARTRIDGE GAP IS CRUCIAL FOR STAPLE FORMATION. WHEN THE CARTRIDGE WELD IS NOT SUFFICIENT, THE GAP WILL BE LARGER THAN OPTIMAL AND STAPLES WILL NOT HIT THE ANVIL CORRECTLY AND IN SOME CASES BYPASSES THE ANVIL RESULTING IN UNFORMED STAPLES. 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. NO BATCH RECORD REVIEW COULD BE PERFORMED AS NO LOT NUMBER WAS PROVIDED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE STAPLE WAS MALFORMED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES FOR 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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1