BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX-5MM ENDO CLIP APPLIER

    MDR report key: 2961956 · Received February 14, 2013

    Report

    Report Number
    3005075853-2013-00629
    Event Type
    Malfunction
    Date Received
    February 14, 2013
    Date of Event
    January 25, 2013
    Report Date
    January 28, 2013
    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: WHICH FIRING OF THE DEVICE DID THIS EVENT OCCUR ON? ---NO INFORMATION. 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 INFORMATION. WAS ANY UNEXPECTED RESISTANCE FELT WHILE FIRING THE TRIGGER? ---NO INFORMATION. WERE ANY UNEXPECTED NOISES HEARD? IF SO, WHEN? ---NO INFORMATION. DID ANYTHING UNEXPECTED HAPPEN PRIOR TO THIS INCIDENT? ---NO INFORMATION. WAS THE DEVICE FIRED AFTER THIS INCIDENT IN OR OUT OF THE PATIENT? ---YES. AFTER THE DEVICE WAS RECEIVED, THE SALES REP FIRED THE DEVICE AND THERE WEREN'T ABNORMALITIES NOTED OF FUNCTION OF THE DEVICE. WHAT WERE THE INDICATIONS FOR SURGERY? WHAT WAS FOUND? ---NO INFORMATION. DOES THE PATIENT HAVE ANY RELEVANT HISTORY OF SURGICAL TREATMENTS? IF SO, WHAT? ---NO INFORMATION. DID SOMEBODY OTHER THAN THE PRIMARY SURGEON FIRE THE INSTRUMENT? IF SO, WHOM? ---NO INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS RESULTS FOUND THAT THE DEVICE WAS RECEIVED IN GOOD VISUAL CONDITION. UPON CYCLING THE DEVICE, IT WAS NOTED TO BE EMPTY AND LOCKED OUT. THE INSTRUMENT IS DESIGNED TO LOCK OUT AFTER ALL THE CLIPS HAVE BEEN FIRED; THEREFORE A POTENTIAL CAUSE OF THE CUSTOMER REPORTED EXPERIENCE IS THE FIRING OF ALL OF THE CLIPS AND THE INSTRUMENT "WILL NOT FIRE" (ACTIVATION OF THE LOCK OUT MECHANISM). THE INSTRUMENT HAS AN ORANGE INDICATOR THAT APPEARS ON THE TOP OF THE HANDLE AS A REFERENCE FOR THE USER AS TO THE QUANTITY OF CLIPS REMAINING. 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 LAPAROSCOPIC CHOLECYSTECTOMY, THE JAWS COULD NOT BE OPENED WHEN THE DEVICE WAS USED ON THE CYSTIC ARTERY. THE DEVICE WAS PULLED AWAY FROM THE CYSTIC ARTERY. ANOTHER DEVICE WAS USED AND ADDITIONAL SUTURE WAS PERFORMED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. THE DOCTOR COMMENTED THAT THE CLIP WAS FED INTO THE JAWS PROPERLY BEFORE THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    65609 LIGAMAX-5MM ENDO CLIP APPLIER CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1