BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIGAMAX-5MM ENDO CLIP APPLIER

    MDR report key: 8744971 · Received June 28, 2019

    Report

    Report Number
    3005075853-2019-20145
    Event Type
    Injury
    Date Received
    June 28, 2019
    Date of Event
    June 17, 2019
    Report Date
    June 18, 2019
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    FZP
    UDI-DI
    10705036001843
    PMA / PMN Number
    K050344
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). BATCH # T9276C. DEVICE ANALYSIS: THE ANALYSIS RESULTS FOUND THAT THE EL5ML DEVICE WAS RETURNED WITH NO DAMAGE IN THE EXTERNAL COMPONENTS. IN AN ATTEMPT TO REPLICATE THE REPORTED INCIDENT, THE INSTRUMENT WAS TESTED FOR FUNCTIONALITY. DURING THE ANALYSIS, THE DEVICE WAS CYCLED AND IT FED AND FORMED 9 CONFORMING CLIPS. UPON TESTING, THE JAWS OPEN AND CLOSE WITHOUT ANY DIFFICULTIES. IN ADDITION, THE DEVICE LOCKED OUT AS INTENDED. NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE REPORTED INCIDENT. THE REPORTED COMPLAINT COULD NOT BE CONFIRMED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE BATCH NUMBER T9276C, AND NO NON-CONFORMANCES WERE IDENTIFIED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE LOT/BATCH WAS NOT PROVIDED; THEREFORE, THE MANUFACTURING RECORD EVALUATION COULD NOT BE PERFORMED. ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED: DID THE SURGEON LOAD AND INSPECT CLIP IN JAW OFF THE VESSEL PRIOR TO FIRING? WAS THERE ANY CLIP FORMATION ISSUE NOTED? IF YES, PLEASE DESCRIBE THEIR SHAPE? WHY WAS THE PROCEDURE CONVERTED TO OPEN? HOW WAS CYSTIC DUCT LIGATED ONCE PROCEEDED TO OPEN? RESPONSE: SURGEON DID NOT PROVIDE ANY MORE INFORMATION AND ENDED THE CONVERSATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY, THE LIGAMAX CLIP APPLIER CUT THE CYSTIC DUCT. HE WOULD NOT ELABORATE FURTHER OTHER THAN WHEN HE WAS APPLYING THE CLIP IT CUT THROUGH THE CYSTIC DUCT AND HE HAD TO REVERT TO OPEN. THE SURGERY WAS DELAYED BUT COMPLETE SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    539978 LIGAMAX-5MM ENDO CLIP APPLIER CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. 10705036001843

    Patients

    Seq Age Sex Outcome Treatment
    1