BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX-5MM

    MDR report key: 2071085 · Received April 27, 2011

    Report

    Report Number
    3005075853-2011-01755
    Event Type
    Malfunction
    Date Received
    April 27, 2011
    Date of Event
    March 30, 2011
    Report Date
    March 30, 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
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). JAWS. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. THE ANALYSIS RESULTS OF THE DEVICE FOUND THAT IT WAS RECEIVED IN GOOD CONDITION. DURING THE FIRST FIRING SEQUENCE ONE JAW RAMP GOT BROKEN CAUSING ONE MALFORMED CLIP A ONE EJECTED CLIP. IN ADDITION, THE DEVICE LOCKED OUT AS INTENDED BUT THE ORANGE VISUAL INDICATOR WAS OVER-TRAVELED. WHEN THIS OCCURS, THE INDICATOR WHEEL MAY CONTINUE TO ROTATE AFTER INDICATION OF A COMPLETELY FIRED DEVICE. PLEASE NOTE THE OVER-TRAVEL OF THE INDICATOR WHEEL IS NOT RELATED TO THE REPORTED EVENT. 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 LAP CHOLE PROCEDURE, THE CYSTIC ARTERY WAS DAMAGED (NOT SURE HOW). IN AN ATTEMPT TO CONTROL THE BLEEDING THE SURGEON ATTEMPTED TO CLIP THE BLEEDING VESSEL. HE FIRED THE CLIPPER UP TO FOURTEEN TIMES IN ALL. UPON FIRING THE FOURTEENTH CLIP THE JAWS OF THE DEVICE BECAME STUCK ON THE TISSUE (HE COULD NOT SEE WHAT AS IT WAS UNDER BLOOD), JAWS JAMMED. THE REP WAS CALLED AND ADVISED VIA THE PHONE TO PULL THE HANDLES APART. THIS WAS DONE SUCCESSFULLY. THE SURGEON DOES NOT THINK HE WAS TWISTING OR TORQUING THE JAWS. HE CANNOT REMEMBER HEARING A NOISE NOR DID HE NOTICE ANYTHING DIFFERENT IN THE HANDLE UNTIL THE JAWS LOCKED. THEY OPENED ANOTHER DEVICE AND MANAGED TO CONTROL THE BLEEDING. SURGERY WAS PROLONGED FIVE MINUTES. 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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1