BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTATING MULTIPLE CLIP APPLIER

    MDR report key: 3905059 · Received July 1, 2014

    Report

    Report Number
    3005075853-2014-04530
    Event Type
    Malfunction
    Date Received
    July 1, 2014
    Date of Event
    June 10, 2014
    Report Date
    June 10, 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
    SP
    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CHOLECYSTECTOMY PROCEDURE WHEN THEY WENT TO CLAMP THE CYSTIC, THE CLIPS WERE BAD FORMED. NO PATIENT CONSEQUENCES REPORTED. PROCEDURE WAS COMPLETED WITH SAME LIKE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    384619 ROTATING MULTIPLE CLIP APPLIER CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1