BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE** RELOADABLE LINEAR STAPLER

    MDR report key: 1992953 · Received February 16, 2011

    Report

    Report Number
    3005075853-2011-00628
    Event Type
    Malfunction
    Date Received
    February 16, 2011
    Report Date
    February 1, 2011
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K020779
    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). PACKAGE WAS VISUALLY EXAMINED. IT WAS NOTED THAT THE DEVICE WAS NOT FULLY SEATED INTO THE PACKAGE AND THE ANVIL WAS PRESSED UP INTO THE TYVEK; THE BLISTER WAS WARPED. IT APPEARS THAT SOMETHING STRUCK THE TYVEK OVER THE ANVIL AND THE TYVEK SHOWED SOME IMPACT DAMAGE FROM THE OUTSIDE IN. DAMAGE WAS EXAMINED UNDER MICROSCOPE AND NO PERFORATION OF THE TYVEK WAS EVIDENT. PACKAGE WAS TESTED USING METHYLENE BLUE AND SOLUTION DID NOT BLEED THROUGH TYVEK, CONFIRMING THAT THERE WAS NO HOLE THROUGH THE TYVEK. COMPLAINT EVENT WAS NOT CONFIRMED. 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.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SET UP FOR AN UNKNOWN PROCEDURE, WHEN THE TECH REVIEWED THE PACKAGE TO OPEN, THERE WAS A HOLE IN THE TYVEK AND THE DEVICE WAS POKING OUT AT THE END. ANOTHER DEVICE WAS USED TO SET UP FOR THE CASE. NO PATIENT INVOLVEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROXIMATE** RELOADABLE LINEAR STAPLER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA G4U87F

    Patients

    Seq Age Sex Outcome Treatment
    1 CARTRIDGE