BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROTATING MULTIPLE CLIP APPLIER

    MDR report key: 2222166 · Received August 24, 2011

    Report

    Report Number
    3005075853-2011-03488
    Event Type
    Injury
    Date Received
    August 24, 2011
    Report Date
    August 1, 2011
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    FZP
    PMA / PMN Number
    K864102
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: THE PATIENT PRESENTED WITH A BILE LEAK POST OPERATIVELY. THE SURGEON BELIEVES THE BILE LEAK WAS "DUE TO CLIP FAILURE". THE SURGEON PERFORMED AN UNPLANNED ERCP AND EVERYTHING LOOKED OKAY. THE PATIENT HAS SINCE RECOVERED AND BEEN DISCHARGED. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED. THE COMPLAINT COULD NOT BE CONFIRMED BECAUSE NO DEVICE WAS RETURNED FOR ANALYSIS. AS A LOT NUMBER WAS NOT RECEIVED, A DEVICE HISTORY REVIEW COULD NOT BE PERFORMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, THE REP STATED THAT THERE IS A "POTENTIAL" PATIENT CONSEQUENCE. THE PATIENT HAS A POST OP LEAK HOWEVER HAS NOT COME BACK TO SURGERY. THE PATIENT IS UNDER OBSERVATION BY THE SURGEON. IT IS UNKNOWN HOW THE LEAK WAS DETERMINED. THE DEVICE WAS DISCARDED. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROTATING MULTIPLE CLIP APPLIER CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1