BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX-5MM

    MDR report key: 2211842 · Received August 15, 2011

    Report

    Report Number
    3005075853-2011-03305
    Event Type
    Malfunction
    Date Received
    August 15, 2011
    Date of Event
    April 25, 2011
    Report Date
    April 28, 2011
    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). ADVANCER. THE ANALYSIS RESULTS FOUND THAT THE DEVICE WAS RETURNED WITH THE TIP OF THE ADVANCER BROKEN. PLEASE NOTE THAT PRIOR TO LOADING A CLIP IN THE JAWS, ENSURE THAT THE DEMARCATION BETWEEN THE JAWS AND THE DEVICE SHAFT IS PAST THE END OF THE TROCAR CANNULA. ADDITIONALLY, EXCESSIVELY APPLYING A SIDE LOAD TO THE JAWS, CAUSING THEM TO PARTIALLY COLLAPSE COULD RESULT IN A CLIP MALFORMATION. THE DEVICE JAWS SHOULD BE FULLY OPEN AND PARALLEL UPON INITIATING THE FIRING OF THE DEVICE. 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 PROSTATECTOMY PROCEDURE, THE CLIPS WOULD NOT ADVANCE. NO CLIP DELIVERED FROM THE FIRST CLIP. THE CLIP WAS CORRECTLY POSITIONED BETWEEN THE JAWS. NO UNUSUAL NOISE HEARD BUT UNEXPECTED RESISTANCE WAS FELT BY A SURGEON. THE DEVICE WAS TESTED OUT OF PATIENT AFTER THE INCIDENT, THE SAME ISSUE OCCURRED. THE SURGEON USED A NEW DEVICE TO PERFORM THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGAMAX-5MM CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA G4UH3C

    Patients

    Seq Age Sex Outcome Treatment
    1