BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIGAMAX 5MM ENDO CLIP APPLIER

    MDR report key: 3790025 · Received May 5, 2014

    Report

    Report Number
    3005075853-2014-03022
    Event Type
    Injury
    Date Received
    May 5, 2014
    Report Date
    April 10, 2014
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    FZP
    PMA / PMN Number
    K050344
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE FOLLOWING INFORMATION HAS BEEN REQUESTED. NO RESPONSE RECEIVED. WERE ANY ISSUES NOTED WITH CLIP FORMATION DURING THE INITIAL OPERATION? WERE ANY ISSUES NOTED WITH FEEDING DURING THE INITIAL OPERATION? WERE ANY ISSUES NOTED WITH THE DELIVERY OF THE CLIP DURING THE INITIAL OPERATION? WAS THE CLIP EVER LOCALIZED? WAS THE CLIP FOUND DURING THE SECOND PROCEDURE? DOES THE SURGEON TYPICALLY USE A ONE STEP OR TWO STEP FIRING PROCESS? WAS THE CYSTIC DUCT ABNORMALLY LARGE OR DIMINUTIVE? WAS A CHOLANGIOGRAM DONE? HOW MANY HOURS OR DAYS POST OP DID THE PATIENT RETURN? HOW MANY CLIPS DOES THE SURGEON TYPICALLY PLACE ON THE PATIENT SIDE? WHAT IS THE PATIENT¿S CURRENT STATUS?

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: WERE ANY ISSUES NOTED WITH CLIP FORMATION DURING THE INITIAL OPERATION? SCISSORING AND NO COMPLETE CLIPS . WERE ANY ISSUES NOTED WITH FEEDING DURING THE INITIAL OPERATION? NO. WAS THE CLIP EVER LOCALIZED? NO. WAS THE CLIP FOUND DURING THE SECOND PROCEDURE? NO STENT PLACED. DOES THE SURGEON TYPICALLY USE A ONE STEP OR TWO STEP FIRING PROCESS? 2. WAS THE CYSTIC DUCT ABNORMALLY LARGE OR DIMINUTIVE? NO. WAS A CHOLANGIOGRAM DONE? NO. HOW MANY HOURS OR DAYS POST OP DID THE PATIENT RETURN? 24. HOW MANY CLIPS DOES THE SURGEON TYPICALLY PLACE ON THE PATIENT SIDE? 2. WHAT IS THE PATIENT¿S CURRENT STATUS? DOING WELL.

    Description of Event or Problem · 1

    IT WAS REPORTED POST OP LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, THE SURGEON REPORTED BILE LEAK AT CYSTIC DUCT. THE PATIENT RETURNED WITH BILE LEAK AND CLIPS FROM DEVICE WERE NO LONGER PRESENT ON CYSTIC DUCT. ONE DEVICE WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    268978 LIGAMAX 5MM ENDO CLIP APPLIER CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. UNK UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention