BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX-5

    MDR report key: 2082419 · Received May 9, 2011

    Report

    Report Number
    3005075853-2011-01889
    Event Type
    Malfunction
    Date Received
    May 9, 2011
    Date of Event
    March 31, 2011
    Report Date
    April 4, 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). ADDITIONAL INFORMATION: WHICH FIRING OF THE DEVICE DID THIS EVENT OCCUR ON? ALTHOUGH WE ASKED THE SALES REP, IT WAS UNK. WHAT VESSEL OR STRUCTURE WAS THE DEVICE FIRED ON AT THE TIME OF THE EVENT? CYSTIC ARTERY. WAS THE CLIP FULLY ADVANCED INTO THE JAWS PRIOR TO FIRING? NO INFORMATION. WAS THERE ANY TORQUING OR TWISTING OF THE DEVICE PRESENT AT THE TIME OF FIRING? NO INFORMATION. WAS ANY UNEXPECTED RESISTANCE FELT WHILE FIRING THE TRIGGER? NO. WERE ANY UNEXPECTED NOISES HEARD? NO. IF SO, WHEN? DID ANYTHING UNEXPECTED HAPPEN PRIOR TO THIS INCIDENT? NO. WAS THE DEVICE FIRED AFTER THIS INCIDENT IN OR OUT OF THE PATIENT? NO INFORMATION. WHAT WERE THE INDICATIONS FOR SURGERY? WHAT WAS FOUND? NO INFORMATION. DOES THE PATIENT HAVE ANY RELEVANT HISTORY OF SURGICAL TREATMENTS? NO INFORMATION. IF SO, WHAT? DID SOMEBODY OTHER THAN THE PRIMARY SURGEON FIRE THE INSTRUMENT? NO INFORMATION. IF SO, WHOM? THE JAW BECAME NOT TO OPEN WITH CLAMPING TISSUE, BUT THE DEVICE WAS RELEASED BY RETURNING THE TRIGGER TO THE HOME POSITION. THE TISSUE WAS NOT DAMAGED. THE ANALYSIS RESULTS FOUND THAT THE DEVICE WAS RECEIVED WITH THE JAWS IN THE CLOSED POSITION. UPON CYCLING THE DEVICE, IT WAS NOTED TO BE EMPTY AND THE LOCKOUT HAD BEEN FIRED THROUGH. PLEASE NOTE THE DEVICE CONTAINS A LOCKOUT FEATURE THAT IS DESIGNED TO INCREASE THE REQUIRED FORCE IT TAKES TO CLOSE THE TRIGGER ONCE THE LAST CLIP HAS BEEN FIRED; THIS REDUCES THE POSSIBILITY OF EMPTY JAWS BEING CLOSED ON A STRUCTURE. IN ADDITION, IF THE TRIGGER IS FORCED CLOSED ONCE THE LOCKOUT HAS BEEN ENGAGED, THE JAWS MAY REMAIN IN THE CLOSED POSITION. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, WHEN THE TRIGGER WAS GRASPED, THE TRIGGER WAS LOCKED AND COULD NOT BE MOVED EVEN IF IT WAS SEPARATED FROM A HAND. THE EVENT OCCURRED SEVERAL TIMES. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGAMAX-5 CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA H4322T

    Patients

    Seq Age Sex Outcome Treatment
    1