BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE** SKIN STAPLER 35 WIDE

    MDR report key: 2183072 · Received July 28, 2011

    Report

    Report Number
    3005075853-2011-03079
    Event Type
    Malfunction
    Date Received
    July 28, 2011
    Date of Event
    July 4, 2011
    Report Date
    July 7, 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
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NONCONFORMING CARTRIDGE WELD. THE ANALYSIS RESULTS CONFIRMED THAT THE DEVICE WAS RECEIVED WITH INSUFFICIENT CARTRIDGE WELD. NO FUNCTIONAL TEST COULD BE PERFORMED WITH THE DEVICE. 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. THE APPROPRIATE ENGINEERING PERSONNEL HAVE BEEN NOTIFIED OF THIS INCIDENT. 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, AFTER 4-5 STAPLES WERE PLACED ON THE SKIN, THE SKIN STAPLER DID NOT WORK ANYMORE. NO PROPER STAPLE FORMATION WAS DONE. THE SURGEON HAD USED ANOTHER STAPLER, BUT IT ALSO WORKED ONLY FOUR FIRING TIMES (INSTEAD OF 35), AFTER THAT IT DID NOT FORM THE STAPLES THE RIGHT WAY. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. 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