BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTATING MULTIPLE CLIP APPLIER

    MDR report key: 4131609 · Received October 1, 2014

    Report

    Report Number
    3005075853-2014-06776
    Event Type
    Malfunction
    Date Received
    October 1, 2014
    Report Date
    September 17, 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
    PO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: DID CLIPS NOT HOLD AND FALL INTO ABDOMINAL CAVITY AFTER THEY WERE APPLIED TO TISSUE? YES DID UNFORMED CLIPS JUST FALL OUT OF DEVICE INTO ABDOMINAL CAVITY (DID DEVICE DROP CLIPS OR EJECT CLIPS)? YES.

    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. THE FOLLOWING INFORMATION WAS REQUESTED, BUT UNAVAILABLE: DID CLIPS NOT HOLD AND FALL INTO ABDOMINAL CAVITY AFTER THEY WERE APPLIED TO TISSUE? DID UNFORMED CLIPS JUST FALL OUT OF DEVICE INTO ABDOMINAL CAVITY (DID DEVICE DROP CLIPS OR EJECT CLIPS)?

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE SURGEON COMPLAINS THAT THE CLIPS DON'T CLOSE WELL AND SEVERAL TIMES THEY SIMPLY FALL INTO ABDOMINAL CAVITY. 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
    612512 ROTATING MULTIPLE CLIP APPLIER CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1