BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX-5MM

    MDR report key: 1963064 · Received January 18, 2011

    Report

    Report Number
    3005075853-2011-00247
    Event Type
    Malfunction
    Date Received
    January 18, 2011
    Date of Event
    December 23, 2010
    Report Date
    December 23, 2010
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    FZP
    PMA / PMN Number
    K050344
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION WAS PROVIDED BY THE HOSPITAL: THE SURGEON ACTUALLY HAD DIFFICULTY WITH TWO DEVICES DURING THIS PROCEDURE AND BOTH WERE RETURNED. THE FIRST DEVICE LOCKED ON THE TISSUE BUT HE WAS ABLE TO MANIPULATE IT A BIT AND IT CAME OFF. WITH THE SECOND DEVICE HE HAD MORE DIFFICULTY GETTING IT OFF AS REPORTED. THE ACCOUNT AGREED ON ADDITIONAL INSERVICING OPPORTUNITIES AND THOUGHT IT WOULD BE A GOOD IDEA FOR EES SALES REP TO REINSERVICE THE STAFF. THE HOSPITAL ALSO CONFIRMED THAT THEY DO NOT REPROCESS THE CLIP APPLIERS OR ANY OF OUR PRODUCTS AT THIS FACILITY. THE PATIENT WAS YOUNG AND HEALTHY. THE SURGEON WANTED TO ENSURE THAT IF AN INFECTION ENSUED (DUE TO EXTENDED OR TIME) IT WOULD BE DETECTED QUICKLY AND THIS IS WHY HE ORDERED HOME HEALTH CARE. HE ALSO ELECTED TO PLACE THE DRAIN DUE TO BILE SPILLAGE DURING THE PROCEDURE. THIS IS NOT PART OF HIS ROUTINE ORDERS. THE REP WAS CONTACTED AND INSERVICING HAS BEEN SCHEDULED WITH THE SURGEON AND STAFF.

    Additional Manufacturer Narrative · 1

    (B)(4). SERIOUS INJURY. FEEDER SHOE. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS RECEIVED: PER THE CONTACT, NOT AWARE OF ANY IMPACT OF PROLONGED PROCEDURE; THE PATIENT HAD A DRAIN PUT IN; WAS RELEASED AND PLACED ON HOME HEALTH MONITORING. THE CONTACT WAS NOT SURE OF THE COMPANY NAME FOR THE HOME HEALTH MONITORING. THE PATIENT HAS SINCE BEEN IN FOR FOLLOW-UP VISITS WITH THE SURGEON. ADDITIONAL INFORMATION WAS REQUESTED FOR FURTHER DETAILS AND THE FOLLOWING WAS PROVIDED: AFTER THE PUNCTURE OF THE GALL BLADDER THE SURGEON IRRIGATED, HOWEVER, DECIDED TO PLACE THE DRAIN DUE TO THE LARGE AMOUNT OF BILE SPILLAGE. HE PLACED THE PATIENT ON HOME HEALTH MONITORING FOR PRECAUTIONARY MEASURES. PATIENT'S INFORMATION: MALE, (B)(6). THE ANALYSIS RESULTS FOUND THAT DEVICE (A) WAS RETURNED FOR ANALYSIS IN GOOD VISUAL CONDITION. AN ATTEMPT TO FIRE THE DEVICE WAS MADE AND THE DEVICE WOULD NOT FEED THE CLIPS. THE DEVICE WAS DISASSEMBLED TO EXAMINE THE CONDITION OF THE INTERNAL COMPONENTS AND THE FEEDER SHOE DRIVE TAB WAS NOTED TO BE DAMAGED, 4 CLIPS WERE FOUND REMAINING ON THE CLIP TRACK. POSSIBLE CAUSES FOR THIS CONDITION MAY BE ACTUATING THE TRIGGER WHILE THE JAWS ARE CLOSED IN A TROCAR OR MOLDED END CAP. THIS COULD ALSO RESULT IF THE TIPS ARE BURIED IN TISSUE WHEN ACTUATION OF THE TRIGGER OCCURS. IT SHOULD BE NOTED, THAT THE JAWS NEED TO BE FULLY OPEN IN ORDER FOR THE NEXT CLIP TO BE PROPERLY FED. HOWEVER, THIS FAILURE MODE IS NOT RELATED WITH THE INCIDENT REPORTED. NO INCIDENT RELATED TO THE REPORTED EVENT WAS OBSERVED DURING THE BATCH RECORD REVIEW. THE ANALYSIS RESULTS FOUND THAT DEVICE (B) 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 ADDITION, THE DEVICE LOCKED OUT AS INTENDED BUT THE ORANGE INDICATOR WAS VISIBLE AT THE 14TH FIRING SEQUENCE THUS, IT WAS NOT COMPLETELY VISIBLE; THIS FINDING IS NOT RELATED WITH THE INCIDENT REPORTED. NO INCIDENT RELATED TO THE REPORTED EVENT WAS OBSERVED DURING THE BATCH RECORD REVIEW. BATCH # G9KZ06 MFG DATE: 9/1/2010; EXP DATE: 8/1/2015, (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME. ATTEMPTS BEING MADE TO OBTAIN ADDITIONAL INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DOCTOR WAS PERFORMING A LAPAROSCOPIC CHOLECYSTECTOMY, ONE CLIP HAD BEEN DEPLOYED USING THE CLIP APPLIER THEN, AS THE CLIP APPLIER LOCKED ONTO THE CYSTIC ARTERY A SECOND TIME AND THE TRIGGER WAS APPLIED TO PLACE THE CLIP AND THE CLIP APPLIER STAYED IN THE LOCKED POSITION. THE DOCTOR WAS ABLE TO REMOVE THE CLIP APPLIER WITH FORCE. THE DOCTOR TRIED A SECOND CLIP APPLIER AND THE SECOND CLIP APPLIER LOCKED ONTO THE CYSTIC ARTERY. THE DOCTOR TRIED REMOVING THE CLIP APPLIER WITH FORCE AND PUNCTURED THE GALL BLADDER. THE DOCTOR USED SCISSORS TO CUT THE SECOND CLIP APPLIER OFF THE TISSUE. A THIRD CLIP APPLIER WAS USED TO APPLY THE REMAINING CLIPS AND THE DOCTOR WAS ABLE TO REMOVE THE GALL BLADDER SUCCESSFULLY. THE PROCEDURE WAS EXTENDED FOR MORE THAN ONE HOUR. PATIENT INFORMATION WAS REQUESTED BUT NONE WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGAMAX-5MM CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA G4TU95

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention