BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX-5MM ENDO CLIP APPLIER

    MDR report key: 2760584 · Received September 26, 2012

    Report

    Report Number
    3005075853-2012-04380
    Event Type
    Malfunction
    Date Received
    September 26, 2012
    Date of Event
    September 19, 2012
    Report Date
    September 20, 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
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS RESULTS FOUND THAT THE INSTRUMENT WAS RETURNED IN GOOD VISUAL CONDITION WITH A BROKEN CLIP INSIDE A PETRI DISH. 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. IN ADDITION THE DEVICE LOCKED OUT AS INTENDED. 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. ADDITIONAL INFORMATION: WHICH FIRING OF THE DEVICE DID THIS EVENT OCCUR ON? 3RD. WHAT VESSEL OR STRUCTURE WAS THE DEVICE FIRED ON AT THE TIME OF THE EVENT? 1ST AND 2ND SIGMOID 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 INFORMATION. WHAT WERE THE INDICATIONS FOR SURGERY? WHAT WAS FOUND? ---NO INFORMATION. DOES THE PATIENT HAVE ANY RELEVANT HISTORY OF SURGICAL TREATMENTS? --NO INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). FRACTURE ANALYSIS: THE CLIP WAS EXAMINED WITH AN OPTICAL MICROSCOPE AND IMAGES OF THE CLIP WERE TAKEN. THE CLIP WAS THEN EXAMINED IN A SCANNING ELECTRON MICROSCOPE (SEM) AND ENERGY DISPERSIVE X-RAY (EDX) ANALYSIS WAS ALSO PERFORMED ON SEVERAL AREAS FOR ANY ANOMALIES IN THE COMPOSITION. THE CAUSE FOR THE CLIP BREAK IS UNKNOWN. THE PRESENCE OF THE BLUISH GOUGE ON THE SIDE INDICATES THERE MAY HAVE BEEN ANOTHER FACTOR CONTRIBUTING TO THE FRACTURE. ONE POSSIBLE CAUSE IS THAT THE CLIP WAS EXPOSED TO ELECTROCAUTERY WHICH CREATED A CURRENT IN THE CLIP. IN THE ENVIRONMENT OF THE BODY THIS MAY HAVE RESULT IN HYDROGEN BEING CREATED FROM THE BODY AND DIFFUSING INTO THE TITANIUM CLIP. UNDER THE PROPER CONDITIONS, AN ELEVATED HYDROGEN CONTENT IN A STRESSED TITANIUM REGION (APEX) CAN CREATE AN EMBRITTLED PHASE AND RESULTED IN A WEAKENED MATERIAL. THERE WERE NO OBSERVED DEFECTS ON THE FRACTURE SURFACE AND NO INDICATION S THAT THE CLIP WAS IMPROPERLY PROCESSED. EDX ANALYSIS ALSO CONFIRMED THAT THE MATERIAL IN THE CLIP WAS TITANIUM AND THAT THE ONLY OTHER ELEMENTS PRESENT WERE THOSE THAT WOULD BE FOUND IN TISSUE AND BODY FLUIDS (C, O, NA, CL, K AND CA).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC SIGMOIDECTOMY PROCEDURE, IT WAS FOUND THAT THE 2/3 FROM THE DISTAL PART OF THE 3RD CLIP WAS BROKEN AND MISSING WHEN THE SURGEON CONFIRMED THE CLIP AT THE END OF THE OPERATION. THE BROKEN CLIP WAS REMOVED FROM THE PATIENT. ALTHOUGH THE BROKEN CLIP WAS ON THE PATIENT'S SIDE, AS ANOTHER CLIP HAD BEEN BEING PLACED ON THE TISSUE BEFORE THE BROKEN CLIP WAS REMOVED, NO ADDITIONAL TREATMENT WAS REQUIRED. THE DEVICE WAS USED FOR THE FIRST AND THE SECOND SIGMOID ARTERY. THE DEVICE WAS FIRED 8 TIMES IN THIS PROCEDURE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO UNEXPECTED RESISTANCE AT THE FIRING. THE DEVICE WAS NOT FIRED ACROSS SOMETHING HARD SUCH AS A CLIP. OTHER CLIPS WERE FORMED AS INTENDED. NO CONVERTION OF THE PROCEDURE DEPENDING ON THE EVENT WAS PERFORMED. NO BLEEDING WAS CONFIRMED. THE CLIP FRAGMENTS WERE NOT CONFIRMED ON X-RAY.

    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