BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIGAMAX CLIP APPLIER

    MDR report key: 3864100 · Received June 10, 2014

    Report

    Report Number
    3005075853-2014-03892
    Event Type
    Injury
    Date Received
    June 10, 2014
    Report Date
    May 13, 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
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): INFORMATION IS UNAVAILABLE. ATTEMPTS HAVE BEEN MADE TO RETRIEVE THE DEVICE. TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT.AT THE TIME OF THIS SUBMISSION, THE DEVICE HAS NOT BEEN RETURNED FOR ANALYSIS. THE FOLLOWING INFORMATION WAS REQUESTED, BUT UNAVAILABLE:PLEASE CLARIFY WHAT IS MEANT BY ¿THE CLIP MAY NOT HAVE HELD¿. WAS THIS OBSERVATION FOUND INTRA-OPERATIVELY OR POST-OPERATIVELY? WAS AN ADDITIONAL SURGICAL PROCEDURE REQUIRED TO ADDRESS THE LEAK? WHAT WAS DONE TO ADDRESS THE LEAK?DURING THE ORIGINAL PROCEDURE WERE THERE ANY ISSUES NOTICED WITH THE FORMATION OF THE CLIP(S)? IF THEY WERE MALFORMED, CAN YOU DESCRIBE THE SHAPE OF THE CLIP? WAS A CHOLANGIOGRAM PERFORMED INTRA-OPERATIVELY? WHAT IS THE PATIENT¿S CURRENT STATUS?WILL THE DEVICE BE RETURNED?

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: THE BILIARY LEAK WAS DISCOVERED A FEW DAYS POST-OP. AN ERCP WAS PERFORMED. PLEASE CLARIFY WHAT IS MEANT BY ¿THE CLIP MAY NOT HAVE HELD.¿ CLIP BECOME DISLODGED FROM COMMON BILE. DURING THE ORIGINAL PROCEDURE WERE THERE ANY ISSUES NOTICED WITH THE FORMATION OF THE CLIP(S)? NONE NOTED. IF THEY WERE MALFORMED, CAN YOU DESCRIBE THE SHAPE OF THE CLIP? WAS A CHOLANGIOGRAM PERFORMED INTRA-OPERATIVELY? YES. WHAT IS THE PATIENT¿S CURRENT STATUS? DISCHARGED HOME. THE DEVICE WAS DISCARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE CLIP MAY NOT HAVE HELD. UNKNOWN HOW CASE WAS COMPLETED. THE PATIENT HAD A BILIARY LEAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    337701 LIGAMAX CLIP APPLIER CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA K4CG0C

    Patients

    Seq Age Sex Outcome Treatment
    1