BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTATING MULTIPLE CLIP APPLIER

    MDR report key: 4182487 · Received October 17, 2014

    Report

    Report Number
    3005075853-2014-07212
    Event Type
    Malfunction
    Date Received
    October 17, 2014
    Date of Event
    September 29, 2014
    Report Date
    September 30, 2014
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    FZP
    PMA / PMN Number
    K864102
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: WAS CHOLANGIOGRAM DONE ON PROCEDURE? NO WAS DEVICE FIRED OVER ANOTHER CLIP OR HARD STRUCTURE? NOT THAT I AM AWARE OF. ON WHICH FIRING DID ISSUE OCCUR? ON THE 3RD FIRING HOW WAS CASE COMPLETED? OPENED ANOTHER CLIP APPLIER. WHAT WAS PROCEDURE DATE AS SYNERGY FORM SAYS (B)(6) 2014 AND UNKNOWN IN EVENT DESCRIPTION? UNKNOWN.

    Additional Manufacturer Narrative · 1

    (B)(4). AFTER FURTHER INVESTIGATION IT WAS DETERMINED THAT THIS REPORT IS A DUPLICATE OF 3005075853-2014-07199. THIS FILE HAS BEEN VOIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, THE CLIPS DID NOT FORM PROPERLY. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    660914 ROTATING MULTIPLE CLIP APPLIER CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA L4E00U

    Patients

    Seq Age Sex Outcome Treatment
    1