BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX-5MM ENDO CLIP APPLIER

    MDR report key: 3221021 · Received July 11, 2013

    Report

    Report Number
    3005075853-2013-03520
    Event Type
    Malfunction
    Date Received
    July 11, 2013
    Date of Event
    May 12, 2013
    Report Date
    July 3, 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
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A VISCERAL PROCEDURE DID NOT OPEN. THE DEVICE GOT LOCKED ON THE PATIENT AFTER APPLYING THE SECOND CLIP. THE DEVICE FIRED ON A CYSTIC ARTERY. THE CLIP WAS NOT FULLY ADVANCED INTO THE JAWS PRIOR TO FIRING. WHILE FIRING, THE SURGEON FELT UNEXPECTED RESISTANCE AND NOISE. THERE WAS NEITHER TORQUING NOR TWISTING OF THE DEVICE AT THE TIME OF FIRING. THE DEVICE HAS NOT BEEN TESTED AFTER THE ISSUE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT. DEVICE NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320544 LIGAMAX-5MM ENDO CLIP APPLIER CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA KC27V

    Patients

    Seq Age Sex Outcome Treatment
    1