BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX-5MM

    MDR report key: 2250815 · Received September 16, 2011

    Report

    Report Number
    3005075853-2011-03828
    Event Type
    Malfunction
    Date Received
    September 16, 2011
    Date of Event
    August 24, 2011
    Report Date
    August 25, 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). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: WHICH FIRING OF THE DEVICE DID THIS EVENT OCCUR ON? ---(B)(6). 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? ---YES. WAS THERE ANY TORQUING OR TWISTING OF THE DEVICE PRESENT AT THE TIME OF FIRING? ---NO. WAS ANY UNEXPECTED RESISTANCE FELT WHILE FIRING THE TRIGGER? ---NO. WERE ANY UNEXPECTED NOISES HEARD? ---NO. DID ANYTHING UNEXPECTED HAPPEN PRIOR TO THIS INCIDENT? ---NO. WAS THE DEVICE FIRED AFTER THIS INCIDENT IN OR OUT OF THE PATIENT? ---NO. WHAT WERE THE INDICATIONS FOR SURGERY? WHAT WAS FOUND? ---NO INFORMATION. DOES THE PATIENT HAVE ANY RELEVANT HISTORY OF SURGICAL TREATMENTS? ---NO INFORMATION. DID SOMEBODY OTHER THAN THE PRIMARY SURGEON FIRE THE INSTRUMENT? ---NO INFORMATION. WAS THERE A RECENT CONVERSION TO EES DEVICES IN THIS ACCOUNT OR WITH THIS SURGEON? ---NO INFORMATION. DID THE SURGEON TRY TO PULL THE TRIGGER FROM THE HANDLE? ---YES. IS THE SURGEON AWARE THAT THE FIRING TRIGGER MAY NEED ASSISTANCE IN RETURNING ALL THE WAY FORWARD? ---YES. HOW WAS THE DEVICE REMOVED? ---NO INFORMATION. WAS THERE ANY TISSUE DAMAGE? ---YES. IF SO, HOW WAS IT REPAIRED? ---SURGICEL WAS USED TO STOP BLEEDING ENDOSCOPICALLY.

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS RESULTS FOUND THAT THE DEVICE WAS RECEIVED IN GOOD VISUAL CONDITION. WHEN TESTING THE DEVICE FOR FUNCTIONALITY IT WAS NOTED TO BE EMPTY AND LOCKED OUT; NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE EVENT REPORTED. 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 CHOLECYSTECTOMY, THE JAWS WERE CLAMPING THE CYSTIC ARTERY AND WOULD NOT TO OPEN AT THE 7TH FIRING. WHILE THE DOCTOR TRIED TO OPEN THE JAWS IN MANY WAYS, THE CYSTIC ARTERY WAS SPILT AND BLEEDING OCCURRED A LITTLE FROM THE SITE. THE HEMOSTASIS WAS PERFORMED SOON WITH ANOTHER DEVICE AND THE OPERATION WAS FINISHED WITHOUT ANY PROBLEM. BLOOD TRANSFUSION WAS NOT REQUIRED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. THE JAWS OPENED OUT OF THE PATIENT'S BODY BY RETURNING THE TRIGGER TO THE HOME POSITION. DESPITE THE 7TH FIRING, THE ORANGE INDICATOR WAS ALREADY SHOWN.

    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