BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX-5MM ENDO CLIP APPLIER

    MDR report key: 3111115 · Received May 14, 2013

    Report

    Report Number
    3005075853-2013-02309
    Event Type
    Malfunction
    Date Received
    May 14, 2013
    Date of Event
    April 4, 2013
    Report Date
    April 5, 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
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). WHAT IS MEANT BY THE DEVICE MISFIRED? SCISSORING CLIPS. WHICH FIRING OF THE DEVICE DID THIS EVENT OCCUR ON? UNKNOWN. WHAT VESSEL OR STRUCTURE WAS THE DEVICE FIRED ON AT THE TIME OF THE EVENT? BLEEDING VESSELS DURING A HERNIA PROCEDURE. WAS THE CLIP FULLY ADVANCED INTO THE JAWS PRIOR TO FIRING? NO. WERE THERE ANY FEEDING ISSUES EXPERIENCED WITH THE DEVICE? UNKNOWN. WAS THE SURGEON ABLE TO VISUALIZE A CLIP FED INTO THE JAWS PRIOR TO FIRING THE DEVICE? NO. WAS THERE ANY TORQUING OR TWISTING OF THE DEVICE PRESENT AT THE TIME OF FIRING? UNKNOWN. WAS ANY UNEXPECTED RESISTANCE FELT WHILE FIRING THE TRIGGER? NO. WERE ANY UNEXPECTED NOISES HEARD? IF SO, WHEN? 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? HERNIA. DOES THE PATIENT HAVE ANY RELEVANT HISTORY OF SURGICAL TREATMENTS? IF SO, WHAT? NO. DID SOMEBODY OTHER THAN THE PRIMARY SURGEON FIRE THE INSTRUMENT? IF SO, WHOM? NO. THE ANALYSIS RESULTS FOUND THAT THE DEVICE (A) 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. 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. THE BATCH HISTORY RECORDS WERE REVIEWED WITH NO ANOMALIES NOTED DURING THE MANUFACTURING PROCESS. THE ANALYSIS RESULTS FOUND THAT THE DEVICE (B) WAS RETURNED IN GOOD VISUAL CONDITION. IN AN ATTEMPT TO REPLICATE THE REPORTED INCIDENT, THE DEVICE WAS TESTED FOR FUNCTIONALITY. UPON FIRING OF THE DEVICE, THE TIP OF THE ADVANCER WAS NOTED BENT CAUSING THAT THE CLIP DID NOT FULLY ADVANCE INTO THE JAW, CAUSING CLIP GAP. ONE POSSIBLE CAUSE FOR THE CONDITION FOUND IS ACTUATING THE DEVICE WHEN THE JAWS ARE NOT CLEAR OF THE TROCAR. HOWEVER, NO SCISSORING WAS OBSERVED DURING FUNCTIONAL TESTING. ACTUATING THE DEVICE WITH THE JAWS CLOSED MAY BEND THE ADVANCER. SUBSEQUENT ACTUATIONS OR MANUAL OPENING OF THE DEVICE MAY BEND THE ADVANCER TIP BACK TOWARD ITS ORIGINAL POSITION AND BREAK THE ADVANCER TIP. PLEASE NOTE THAT PRIOR TO LOADING A CLIP IN THE JAWS, ENSURE THAT THE DEMARCATION BETWEEN THE JAWS AND THE DEVICE SHAFT IS PAST THE END OF THE TROCAR CANNULA. ADDITIONALLY, EXCESSIVELY APPLYING A SIDE LOAD TO THE JAWS, CAUSING THEM TO PARTIALLY COLLAPSE COULD RESULT IN A CLIP MALFORMATION. THE DEVICE JAWS SHOULD BE FULLY OPEN AND PARALLEL UPON INITIATING THE FIRING OF THE DEVICE. IN ADDITION, THE DEVICE LOCKED OUT AS INTENDED. THE BATCH HISTORY RECORDS WERE REVIEWED WITH NO ANOMALIES NOTED DURING THE MANUFACTURING PROCESS. DEVICE B ADDITIONAL INFORMATION: BATCH # J92Z9Y; EXPIRATION DATE: 11/2017; MANUFACTURING DATE: 12/2012. THE ANALYSIS RESULTS OF THE DEVICE (C) FOUND THAT IT WAS RECEIVED IN GOOD VISUAL CONDITION. UPON EVALUATION THE DEVICE FIRED TWO CLIPS INTERMITTENTLY BOTH OF THEM, CONFORMING. IN ADDITION, THE DEVICE DID NOT LOCKOUT AS INTENDED. IN ORDER TO EVALUATE THE CONDITION OF THE INTERNAL COMPONENTS OF THE DEVICE, IT WAS DISASSEMBLED. UPON DISASSEMBLING, EXCESSIVE DRIED BODY FLUIDS WERE NOTED IN THE HANDLE OF THE DEVICE. IT IS POSSIBLE THAT THE DRIED BODY FLUIDS COULD HAVE PREVENTED TO PROPER FEEDING OF THE CLIP INTO THE JAW. IN ADDITON, THE EXCESSIVE BODY FLUIDS COULD HAVE AFFECTED THE LOCKOUT FUNCTIONALITY OF THE DEVICE. ACCUMULATION OF BODY FLUIDS IS A ROUTINE OCCURRENCE DURING SURGICAL PROCEDURES AND DOES NOT NECESSARILY INDICATE A MANUFACTURING DEFECT IN THE DEVICE. THE BATCH HISTORY RECORDS WERE REVIEWED WITH NO ANOMALIES NOTED DURING THE MANUFACTURING PROCESS. DEVICE C ADDITIONAL INFORMATION: BATCH # J92Z9Y; EXPIRATION DATE: 11/2017; MANUFACTURING DATE: 12/2012.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC INGUINAL HERNIA REPAIR PROCEDURE, IT WAS REPORTED ALL THREE DEVICES MISFIRED. A FOURTH DEVICE WAS OPENED AND THE CASE WAS COMPLETED NO PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    213427 LIGAMAX-5MM ENDO CLIP APPLIER CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA J4CT6T

    Patients

    Seq Age Sex Outcome Treatment
    1