BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX-5MM

    MDR report key: 2200028 · Received August 10, 2011

    Report

    Report Number
    3005075853-2011-03249
    Event Type
    Malfunction
    Date Received
    August 10, 2011
    Date of Event
    July 15, 2011
    Report Date
    July 22, 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
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS RESULTS FOUND THAT THE DEVICE WAS RECEIVED WITH ON CAM RAMP BROKEN MAKING THE INSTRUMENT NON-FUNCTIONAL. THE DEVICE WAS SENT TO THE LAB FOR FURTHER EVALUATION AND THE RESULTS STATES AS FOLLOWS: THE DEVICE WAS EXAMINED AND PHOTOGRAPHED WITH AN OPTICAL MICROSCOPE. THE FRACTURE SURFACE OF THE CAM WAS THEN EXAMINED AND PHOTOGRAPHED WITH THE SCANNING ELECTRON MICROSCOPE (SEM). THE SEM EXAMINATION OF THE FRACTURE SURFACE WAS PARTIALLY COVERED WITH CORROSION, MOST LIKELY FROM LIQUIDS THE DEVICE WAS EXPOSED TO DURING AND AFTER THE SURGERY. MOST OF THE FRACTURE SURFACE IS INTERGRANULAR WHICH IS A MODE OF FRACTURE WHEN THE ALLOY BREAKS ALONG THE GRAIN BOUNDARIES IN A BRITTLE MODE. THIS IS USUALLY CAUSED BY CORROSIVE FLUIDS (SALINE, BLOOD, DISINFECTANTS) PRESENT ON A PART WHILE IT IS UNDER STRESS. THIS CONDITION IS VERY UNLIKELY TO OCCUR DURING A SURGICAL PROCEDURE AND IS MOST LIKELY TO OCCUR AFTER SHIPPING FROM THE HOSPITAL BEFORE RECEIPT AT THE MANUFACTURER. PLEASE NOTE THAT THIS CONDITION IS UNRELATED TO THE REPORTED INCIDENT.

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS RESULTS FOUND THAT THE DEVICE WAS RECEIVED WITH ON CAM RAMP BROKEN MAKING THE INSTRUMENT NON-FUNCTIONAL. ALTHOUGH THE RETURNED CONDITION OF THE DEVICE PREVENTED FUNCTIONAL TESTING TO EVALUATE THE REPORTED INCIDENT, THE LOCKOUT MECHANISM WAS IN A CONDITION THAT PERMITTED FURTHER EVALUATION. DURING THIS TESTING, THE DEVICE LOCKED OUT AS INTENDED BUT THE ORANGE INDICATOR OVER TRAVELED. WHEN THIS OCCURS, THE INDICATOR WHEEL MAY CONTINUE TO ROTATE AFTER INDICATION OF A COMPLETELY FIRED DEVICE. THE OVER-TRAVEL OF THE INDICATOR WHEEL AND THE CAM CONDITION ARE NOT RELATED TO THE REPORTED EVENT. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: WHAT VESSEL OR STRUCTURE WAS THE DEVICE FIRED ON AT THE TIME OF THE EVENT? ---BLOOD VESSEL. WAS ANY UNEXPECTED RESISTANCE FELT WHILE FIRING THE TRIGGER? ---YES. DID ANYTHING UNEXPECTED HAPPEN PRIOR TO THIS INCIDENT? ---THE DOCTOR FELT A DIFFICULTY IN FIRING. HOW WAS THE DEVICE REMOVED? ---OTHER CLIPS WERE FIRED ON BOTH SIDES OF THE JAWS AND THE TISSUE WAS CUT WITH AN ELECTRICAL SCALPEL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, THE DOCTOR FELT A FEELING OF STRANGENESS, AND THEN SOME CLIPS WERE MALFORMED. EVENTUALLY, THE JAW BECAME NOT TO OPEN. BOTH SIDES OF THE JAWS WERE FIRED WITH ANOTHER CLIPPING DEVICE, AND THE SITE WAS CUT WITH AN ELECTRICAL SCALPEL. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGAMAX-5MM CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA H4369K

    Patients

    Seq Age Sex Outcome Treatment
    1