BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX-5MM ENDO CLIP APPLIER

    MDR report key: 2875110 · Received December 17, 2012

    Report

    Report Number
    3005075853-2012-05743
    Event Type
    Malfunction
    Date Received
    December 17, 2012
    Date of Event
    December 2, 2012
    Report Date
    December 3, 2012
    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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: HOW WAS THE BLEEDING STOPPED? ADDED MORE CLIPS. WHAT WAS THE QUANTITY OF BLOOD LOSS? N/A. WAS THERE TRANSFUSION OR BLOOD PRODUCTS REQUIRED? NO. WAS THERE AN ADVERSE PATIENT CONSEQUENCE? NOT DURING THE SURGERY BUT THIS RISKS FOR HIGHER POST OP PROBLEMS. WHICH FIRING OF THE DEVICE DID THIS EVENT OCCUR ON? FIRST 5. WHAT VESSEL OR STRUCTURE WAS THE DEVICE FIRED ON AT THE TIME OF THE EVENT? CYSTIC ARTERY AND CYSTIC DUCT. WAS THE CLIP FULLY ADVANCED INTO THE JAWS PRIOR TO FIRING? YES. WAS THERE ANY TORQUING OR TWISTING OF THE DEVICE PRESENT AT THE TIME OF FIRING? N/A. 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? YES, FIRED ANOTHER SAMPLE CLIP TO SEE HOW IT DELIVERS OUT OF THE PATIENT. WHAT WERE THE INDICATIONS FOR SURGERY? GALLBLADDER ISSUES WHAT WAS FOUND? DOES THE PATIENT HAVE ANY RELEVANT HISTORY OF SURGICAL TREATMENTS? IF SO, WHAT? N/A. DID SOMEBODY OTHER THAN THE PRIMARY SURGEON FIRE THE INSTRUMENT? NO.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: HOW WAS THE BLEEDING STOPPED? ADDED MORE CLIPS. WHAT WAS THE QUANTITY OF BLOOD LOSS? N/A. WAS THERE TRANSFUSION OR BLOOD PRODUCTS REQUIRED? NO. WAS THERE AN ADVERSE PATIENT CONSEQUENCE? NOT DURING THE SURGERY BUT THIS RISKS FOR HIGHER POST OP PROBLEMS. WHICH FIRING OF THE DEVICE DID THIS EVENT OCCUR ON? FIRST 5. WHAT VESSEL OR STRUCTURE WAS THE DEVICE FIRED ON AT THE TIME OF THE EVENT? CYSTIC ARTERY AND CYSTIC DUCT. WAS THE CLIP FULLY ADVANCED INTO THE JAWS PRIOR TO FIRING? YES. WAS THERE ANY TORQUING OR TWISTING OF THE DEVICE PRESENT AT THE TIME OF FIRING? N/A. 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? YES, FIRED ANOTHER SAMPLE CLIP TO SEE HOW IT DELIVERS OUT OF THE PATIENT. WHAT WERE THE INDICATIONS FOR SURGERY? GALLBLADDER ISSUES WHAT WAS FOUND? DOES THE PATIENT HAVE ANY RELEVANT HISTORY OF SURGICAL TREATMENTS? IF SO, WHAT? N/A. DID SOMEBODY OTHER THAN THE PRIMARY SURGEON FIRE THE INSTRUMENT? NO.

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS RESULTS FOUND THAT THE DEVICE WAS RETURNED IN GOOD VISUAL CONDITION. IN AN ATTEMPT TO REPLICATE THE REPORTED INCIDENT, THE DEVICE WAS TESTED FOR FUNCTIONALITY. UPON TESTING, THE DEVICE WAS CYCLED, FED, AND FORMED THE REMAINING CLIPS AS INTENDED. IN ORDER TO CONFIRM THE CLIPS WERE WITHIN MANUFACTURING SPECIFICATIONS, THE CLIPS WERE EVALUATED USING A TOOL THAT IS DESIGNED TO DETERMINE PROPER FORMATION. DURING ANALYSIS THE JAWS OPEN AND CLOSE AS INTENDED. IN ADDITION THE DEVICE LOCKED OUT AS INTENDED. NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE REPORTED INCIDENT. THIS REPORT IS NOT INTENDED TO DENY THAT YOU EXPERIENCED A PROBLEM WITH THE DEVICE. THERE MAY HAVE BEEN OTHER CIRCUMSTANCES OR ISSUES THAT OCCURRED DURING THE USE OF THE DEVICE THAT WE WERE UNABLE TO DUPLICATE DURING OUR LABORATORY ANALYSIS. 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 LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, THE CLIPS WERE NOT CLOSING PROPERLY AND WERE NOT SEALING THE VESSEL. HE SAID THAT THE CLIPS WERE SIZZLING AND CROSSING WHEN THEY WERE FIRED AND IN TURN DID NOT SEAL THE VESSEL AND CAUSED MORE BLEEDING. IT IS UNKNOWN HOW THE CASE WAS COMPLETED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1