BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX 5MM

    MDR report key: 4122984 · Received September 26, 2014

    Report

    Report Number
    3005075853-2014-06696
    Event Type
    Malfunction
    Date Received
    September 26, 2014
    Date of Event
    August 26, 2014
    Report Date
    August 28, 2014
    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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS RESULTS FOR THE EL5ML DEVICE FOUND THAT IT WAS RETURNED WITH THE SHAFT BENT. A BAG WITH ONE MALFORMED CLIP WAS RECEIVED ALONG WITH THE INSTRUMENT. NO FUNCTIONAL TESTING COULD BE PERFORMED DUE TO THE RETURNED CONDITION OF THE DEVICE. POSSIBLE CAUSES FOR THE DAMAGE FOUND MAY BE INADVERTENT PRESSURE PLACED ON THE DEVICE SHAFT THROUGH BENDING, PRESSING AGAINST THE TROCAR, OTHER DEVICES ON THE BACK TABLE, USING THE DEVICE AS A RETRACTOR OR MOVING HEAVY TISSUE WITH THE DEVICE SHAFT. HOWEVER, IT COULD NOT BE DETERMINED WHAT TO MAY HAVE CAUSED THE REPORTED INCIDENT. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, THE DEVICE JAMMED WITH THE JAWS CLOSED WHEN DEPLOYING A CLIP. THE JAWS EVENTUALLY OPENED AND ANOTHER DEVICE WAS USED TO COMPLETE THE CASE WITHOUT INCIDENT. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601210 LIGAMAX 5MM CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1