BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX-5MM ENDO CLIP APPLIER

    MDR report key: 1914207 · Received December 3, 2010

    Report

    Report Number
    3005075853-2010-06852
    Event Type
    Malfunction
    Date Received
    December 3, 2010
    Date of Event
    November 9, 2010
    Report Date
    November 9, 2010
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    FZP
    PMA / PMN Number
    K050344
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). FEED LINK AND ADVANCER THE DEVICE WAS RECEIVED WITH A J-SHAPE CLIP IN THE JAWS. THE JAWS WERE INSPECTED AND NO BURR WAS FOUND. IN AN ATTEMPT TO REPLICATE THE REPORTED INCIDENT, THE DEVICE WAS TESTED FOR FUNCTIONALITY. UPON FIRING OF THE DEVICE, THE CLIPS COULD NOT BE FED INTO THE JAWS. IN ORDER TO EVALUATE THE DEVICE'S INTERNAL COMPONENTS THE DEVICE WAS DISASSEMBLED. UPON DISASSEMBLING OF THE DEVICE, THE FEED LINK WAS NOTED BROKEN, THE TIP OF THE ADVANCER WAS BENT AND EIGHT CLIPS WERE FOUND ADHERED TO THE CLIP TRACK BY DRIED BODY FLUIDS. ACCUMULATION OF BODY FLUIDS IS A ROUTINE OCCURRENCE DURING SURGICAL PROCEDURES AND DOES NOT NECESSARILY INDICATE A MANUFACTURING DEFECT IN THE DEVICE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED: WAS THERE AN ACTUAL HEMOSTASIS /COAGULATION ISSUE OR DID THE DEVICE JUST NOT WORK, SUCH AS IT STOPPED ACTIVATING? ---IT WAS HEMOSTASIS ISSUE. IF THERE WAS A HEMOSTASIS ISSUES, HOW MUCH BLOOD WAS LOST? --- NO DETAILED INFORMATION. BUT THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. WAS THE PROCEDURE OPEN, SINGLE SITE, ROBOTIC, ETC.? ---LAPAROSCOPIC. WERE THEY USING THE DEVICE IN SINGLE TAP OR DOUBLE TAP MODE. ---NO INFORMATION. DID THEY GET THE CONFIRMATION TONE FROM THE GENERATOR OR JUST THE CYCLE COMPLETE CHIRP, CHIRP AT THE END OF 15 SECONDS OR 2 MINUTES? ---NO INFORMATION. IS THE SURGEON AN EXPERIENCED ENSEAL USER? ---NO. THE SURGEON WAS LIGASURE USER AND HE/SHE USED ENSEAL FOR THE FIRST TIME. IF YES, HOW MANY CASES? ---N/A. APPROXIMATELY HOW MANY TIMES HAD THEY FIRED THE INSTRUMENT DURING THE PROCEDURE? (E.G., WAS THIS EARLY IN THE PROCEDURE OR LATER? ---THIS HAPPENED A FEW TIMES FROM THE BEGINNING TO THE LAST. WAS THIS THE ONLY TIME DURING THE PROCEDURE THAT HEMOSTASIS WAS NOT ACHIEVED? ---NO. WERE THEY GOING THROUGH TOUGH TISSUE? --- NO INFORMATION. WAS THERE A REPLACE DEVICE WARNING (AUDIBLE BEEPS AND LIGHT)? --- NO. WAS EXCESSIVE GRASPING FORCE USED? --- NO INFORMATION. DID THE PATIENT HAVE PRIOR SURGERIES? --- NO INFORMATION. WAS A TRANSFUSION REQUIRED? ---NO. HOW WAS BLOOD LOSS CONTROLLED? DESCRIBE HOW: --- ASTRICTION WAS PERFORMED WITH GAUZE. WAS ANY MEDICAL INTERVENTION USED? (SUCH AS CONVERT TO OPEN TO CONTROL) --NO. WAS THE CONVERT TO OPEN A DIRECT RESULT OF THE LACK OF COAGULATION? ---N/A. WHAT WAS THE SIZE OF THE VESSEL OR ARTERY? ---NO INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, ON THE SECOND FIRING THE CLIPS WERE "J" SHAPED. ON THE THIRD FIRING THE DEVICE LOCKED OUT. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT IMPACT. (B)(4)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGAMAX-5MM ENDO CLIP APPLIER CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. G4TY6T

    Patients

    Seq Age Sex Outcome Treatment
    1