BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    75MM NTLC SELECTABLE RELOAD

    MDR report key: 3072898 · Received April 23, 2013

    Report

    Report Number
    3005075853-2013-01923
    Event Type
    Malfunction
    Date Received
    April 23, 2013
    Date of Event
    March 28, 2013
    Report Date
    March 28, 2013
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K092577
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION UNAVAILABLE. ELEVEN PACKAGES WERE RECEIVED, TEN EXHIBITED NO DAMAGE,A HOLE IN A PACKAGE WAS CONFIRMED. PACKAGE CONTAINED AN ARRAY OF HOLES ON THE TYVEK LID. THE HOLES ARE ARRANGED IN WHAT APPEARS TO BE A PATTERN. THE HOLES THEMSELVES HAVE A DISTINCT DIAMOND PATTERN AS WELL. BASED ON THE VISUAL INSPECTION OF THE LID, IT APPEARS THAT INK FROM THE FLEXOGRAPHIC PRINTER ON THE PACKAGING MACHINE EXISTS ON PORTIONS OF THE DAMAGED RAW MATERIAL. BASED ON THE EXAMINATION OF THE DAMAGE, IT IS CONCLUDED THAT THE DAMAGE WAS CAUSED BY SOME TYPE OF IMPACT TO THE TYVEK MATERIAL WHILE IT WAS POSSIBLY IN CONTACT WITH A HARD SURFACE. THE HOLES APPEAR TO PUCKER FROM THE ADHESIVE SIDE OF THE MATERIAL OUTWARD TO THE NON-ADHESIVE SIDE. BASED ON THE INVESTIGATION INTO THE PACKAGING AND SUPPLIER PROCESS AND THE VISUAL INSPECTION OF THE SAMPLE, IT IS SUSPECTED THAT THE DAMAGE TO THE SAMPLE WAS CAUSED BY AN IMPACT FORCE TO THE TYVEK, BUT IT IS UNKNOWN HOW OR WHEN THE DAMAGE COULD HAVE OCCURRED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A DAMAGE LHOLE OR RIP WAS FOUND ON THE TYVEK IN A PACKAGE. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    175040 75MM NTLC SELECTABLE RELOAD STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK K4C65M

    Patients

    Seq Age Sex Outcome Treatment
    1