BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX-5MM ENDO CLIP APPLIER

    MDR report key: 7806051 · Received August 22, 2018

    Report

    Report Number
    3005075853-2018-12277
    Event Type
    Malfunction
    Date Received
    August 22, 2018
    Date of Event
    August 9, 2018
    Report Date
    August 9, 2018
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    FZP
    UDI-DI
    20705036001840
    PMA / PMN Number
    K050344
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BATCH # UNK. AS A LOT/BATCH WAS NOT PROVIDED, A DEVICE HISTORY COULD NOT BE PERFORMED. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: DID THE CLIPS SCISSOR? YES. DID THE JAWS SCISSOR? NO. NO FURTHER INFORMATION WILL BE PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LDG, SCISSORING OCCURRED WHEN THE DEVICE WAS FIRED ON THE ARTERY UNDER THE PYLORUS. THE SAME EVENT OCCURRED FREQUENTLY WHEN THE DEVICE WAS FIRED OUTSIDE THE PATIENT FOR FUNCTIONALITY. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    645146 LIGAMAX-5MM ENDO CLIP APPLIER CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. UNK 20705036001840

    Patients

    Seq Age Sex Outcome Treatment
    1