BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX-5MM ENDO CLIP APPLIER

    MDR report key: 2992231 · Received March 7, 2013

    Report

    Report Number
    3005075853-2013-01109
    Event Type
    Malfunction
    Date Received
    March 7, 2013
    Date of Event
    February 21, 2013
    Report Date
    February 21, 2013
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    FZP
    PMA / PMN Number
    K050344
    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 ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). COMPLAINT INDICATED A WRINKLE IN THE HEAT SEAL AREA. SALES UNIT AND PACKAGES WERE VISUALLY EXAMINED. THE CARTON WAS FOUND TO BE OPENED AND DAMAGED. THREE PACKAGES WERE FOUND TO BE UNDAMAGED. TWO OF THE PACKAGES HAD NO DEFECTS. ONE PACKAGE HAD A TYVEK WRINKLE ACROSS THE SEAL AREA OF THE PACKAGE. THE WRINKLE WAS IN AN AREA OF TYVEK GLAZING WHICH CAUSED THE TYVEK TO HAVE A TRANSLUCENT APPEARANCE. THE PACKAGE WAS OPENED TO VISUALLY EXAMINE THE GLAZING AND THE WRINKLED AREA OF THE TYVEK AND BLISTER. THE PACKAGE SEAL WAS FOUND TO BE INTACT AND PACKAGE STERILITY WAS NOT COMPROMISED. 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.

    Description of Event or Problem · 1

    RECEIVED THE PRODUCT(S) AND DURING INCOMING/LABELING OPERATION FOUND THE FOLLOWING DEFECT. DETAILS OF THE DEFECT IS WRINKLE ON THE HEAT-SEALING. DEVICE WILL BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97706 LIGAMAX-5MM ENDO CLIP APPLIER CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA K4C26M

    Patients

    Seq Age Sex Outcome Treatment
    1