BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIGAMAX CLIP APPLIER

    MDR report key: 4100801 · Received September 19, 2014

    Report

    Report Number
    3005075853-2014-06516
    Event Type
    Injury
    Date Received
    September 19, 2014
    Date of Event
    July 30, 2014
    Report Date
    August 18, 2014
    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
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION WAS NOT PROVIDED BY THE INITIAL CONTACT. EMPTY. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: WAS CLIP MALFORMED? NO, THE CLIP CAME IN OBLIQUE. WAS CLIP SCISSORED? THE CLIP CUT THE ARTERY BECAUSE IT CAME IN OBLIQUE. DID CLIP FEED AND FIRE SIDEWAYS? UNKNOWN. WAS THERE BLEEDING THAT OCCURRED WHEN ARTERY DAMAGED? IT BLEED A LOT BECAUSE THE CLIP DAMAGED THE ARTERY. IF BLEEDING, HOW MUCH BLEEDING OCCURRED (PLEASE QUANTIFY AMOUNT)? THE PATIENT HAD TO BE TRANSFUSED. WERE BLOOD PRODUCTS GIVEN TO PATIENT? YES. WAS NEW EL5ML SUFFICIENT TO CONTROL BLEEDING AND REPAIR ARTERY? NO. WAS THERE ANY CHANGE TO PROCEDURE OR POST-OP PATIENT CARE? TRANSFUSION. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. DID THE PROCEDURE DRIVE THE NEED TO APPLY TORQUE? WERE THERE ANY ISSUES EXPERIENCED WITH THE SECOND DEVICE? HOW WAS THE PROCEDURE COMPLETED? HOW MUCH BLOOD DID THE PATIENT RECEIVE IN THE TRANSFUSION? WHAT IS THE PATIENT¿S CURRENT STATUS? THE ANALYSIS RESULTS FOUND THAT THE EL5ML DEVICE WAS RECEIVED IN GOOD VISUAL CONDITION. UPON CYCLING THE DEVICE, IT WAS NOTED TO BE EMPTY AND LOCKED OUT. THE DEVICE IS DESIGNED TO LOCK OUT WHEN ALL THE CLIPS HAVE BEEN FIRED. DUE TO THE CONDITION OF THE DEVICE, NO FUNCTIONAL TESTING COULD BE PERFORMED TO EVALUATE THE INCIDENT REPORTED. NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE EVENT REPORTED. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A BLADDER PROCEDURE, WHEN THE SURGEON USED THE DEVICE, THE CLIP WENT IN OBLIQUE AND IT DAMAGED THE ARTERY. THE DOCTOR WAS ABLE TO CONTROL THE DAMAGE. WHEN THE PRODUCT SPECIALIST TESTED THE DEVICE, THE DEVICE WAS EMPTY AND THE WINDOW WAS NOT RED. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS A DAMAGED ARTERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    582082 LIGAMAX CLIP APPLIER CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA L4ED2L

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention