BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE** RELOADABLE LINEAR CUTTER WITH SAFTEY LOCK-OUT

    MDR report key: 2981590 · Received February 27, 2013

    Report

    Report Number
    3005075853-2013-00894
    Event Type
    Malfunction
    Date Received
    February 27, 2013
    Report Date
    February 4, 2013
    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
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PACKAGING CONFORMING THE CUSTOMER COMPLAINT INDICATED THAT THE TYVEK "WAS TORN A LITTLE WHICH COMPROMISED STERILITY." THE PACKAGE WAS VISUALLY EXAMINED AND IT WAS FOUND THAT THE PACKAGE HAD BEEN PARTLY PEELED OPEN ON THE END OPPOSITE THE PEEL TAB. THE PACKAGE SHOWED EVIDENCE OF SEAL ADHESIVE TRANSFER FROM THE TYVEK ONTO THE BLISTER INDICATING THAT THE PACKAGE HAD BEEN COMPLETELY SEALED PRIOR TO BEING OPENED. THERE WAS NO INDICATION OF POTENTIAL CONTAMINATION OF THE PACKAGE THAT COULD HAVE ADVERSELY AFFECTED THE SEAL. THE TYVEK WAS VISUALLY INSPECTED AND NO RIP DAMAGE WAS FOUND. COMPLAINT EVENT COULD NOT BE VERIFIED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO AN UNKNOWN PROCEDURE WHEN THE SCRUB TECH PULLED THE DEVICE OUT OF THE BOX THE TYVEK WAS ALLEGED TO HAVE BEEN TORN WHICH COMPROMISED STERILITY. THE DEVICE WAS NOT USED ON THE PATIENT. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE WITH NO PATIENT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    83510 PROXIMATE** RELOADABLE LINEAR CUTTER WITH SAFTEY LOCK-OUT STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK J4CK48

    Patients

    Seq Age Sex Outcome Treatment
    1