BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP*MCA SMALL APPLIER

    MDR report key: 2901705 · Received January 8, 2013

    Report

    Report Number
    3005075853-2013-00127
    Event Type
    Malfunction
    Date Received
    January 8, 2013
    Date of Event
    December 26, 2012
    Report Date
    December 26, 2012
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDO
    PMA / PMN Number
    K820837
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 6 COMPLAINT INDICATED THAT THE PACKAGE WAS DAMAGED TO EITHER THE FILM OR THE TYVEK AND THE BLISTER DEFORMED DUE TO DEVICE LOADED NOT PROPERLY. ONE (1) SALES UNIT WAS RETURNED FOR ANALYSIS WITH SIX (6) SEALED PACKAGES IN THE BOX. THE CARTON WAS IN GOOD CONDITION. INDIVIDUAL PACKAGES INSIDE THE SALES UNIT (6 PACKAGES TOTAL) WERE VISUALLY INSPECTED FOR DAMAGE TO THE PACKAGE. ONE (1) PACKAGE WAS CONFIRMED TO HAVE A HOLE IN THE TYVEK TOPSTOCK MATERIAL CREATING A BREACH OF STERILITY IN THE PACKAGE. THE REMAINING FIVE (5) PACKAGES HAD NO DAMAGE TO THE PACKAGES. THE DEVICE WAS NOT LOADED INTO THE (CAVITY A) BLISTER FORM CORRECTLY, AS IT WAS NOT SNAPPED INTO PACKAGE DETENTS. THIS CAUSED A CRUSH IN THE BLISTER CORNER WHERE THE DEVICE PRESSED AGAINST THE BLISTER AS IT TRANSITED THROUGH THE PACKAGING SEAL STATION. THE DEVICE PROFILE WAS ABOVE THE PLANE OF THE SEAL AND WHEN SEAL PLATE PRESSED DOWN, IT PUSHED THE TYVEK DOWN OVER THE DEVICE HANDLE RESULTING IN A HOLE. UNDER BLACK LIGHT INSPECTION, THE LOCATION OF THE HOLE IN TYVEK LINED UP WITH THE HANDLE AND THAT LOCATION ON THE HANDLE SHOWED EVIDENCE OF SEAL TRANSFER. THE SEAL TRANSFER INDICATES THAT THE HANDLE WAS PROTRUDING INTO THE TYVEK LID AS A MISLOAD IN PACKAGING PRIOR TO THE HEATING AT THE SEAL STATION. COMPLAINT EVENT IS CONFIRMED. LOT HISTORY RECORDS WERE REVIEWED. 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).

    Description of Event or Problem · 1

    DURING INCOMING OPERATION FOUND THE FOLLOWING DEFECT. DETAILS OF THE DEFECT IS DAMAGE LIKE A HOLE OR RIP ON TYVEK IN A PACKAGE AND THE BLISTER DEFORMED DUE TO THE DEVICE LOADED NOT PROPERLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    9452 LIGACLIP*MCA SMALL APPLIER CLIP, IMPLANTABLE GDO ETHICON ENDO-SURGERY, LLC. NA J4CM75

    Patients

    Seq Age Sex Outcome Treatment
    1