BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE ILS CURVED CIR STAPL

    MDR report key: 2071550 · Received April 28, 2011

    Report

    Report Number
    3005075853-2011-01764
    Event Type
    Malfunction
    Date Received
    April 28, 2011
    Report Date
    April 13, 2011
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K983536
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). BLISTER AND TYVEK WERE RETURNED FOR ANALYSIS WITH NO INSTRUMENT. TYVEK HAD BEEN FOLDED OVER AND WAS ON TOP OF THE BLISTER. TYVEK LID WAS VISUALLY EXAMINED FOR CONTAMINATION OR ANY OTHER DEFECT. NO CONTAMINATION WAS FOUND ON THE TYVEK AND, THOUGH FOLDED, THERE WAS NO DAMAGE TO THE TYVEK. BLISTER WAS VISUALLY EXAMINED. THERE WAS NO DAMAGE ON THE BLISTER AND THERE WAS EVIDENCE OF COMPLETE SEAL TRANSFER FROM TYVEK ON ENTIRE CIRCUMFERENCE OF BLISTER FLANGE. PARTICLES OF BLACK PLASTIC FOREIGN MATTER WERE TAPED TO THE INSIDE SURFACE OF THE BLISTER. PLASTIC APPEARS TO BE DEBRIS FROM THE INSTRUMENT. BATCH HISTORY RECORDS WERE REVIEWED WITH NO PROTOCOLS, DEFECTS, NON-CONFORMANCES OR QUARANTINE NOTED. THE PRODUCT MET ALL IN-PROCESS AND FINISHED GOODS SPECIFICATIONS UPON RELEASE OF THE PRODUCT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BEFORE AN UNKNOWN PROCEDURE, STERILITY PACKAGE IS CONTAMINATED; NO FURTHER INFORMATION IS AVAILABLE. 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 ILS CURVED CIR STAPL STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA G4U947

    Patients

    Seq Age Sex Outcome Treatment
    1