BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTATING MULTIPLE CLIP APPLIER

    MDR report key: 3914128 · Received July 3, 2014

    Report

    Report Number
    3005075853-2014-04658
    Event Type
    Malfunction
    Date Received
    July 3, 2014
    Date of Event
    April 9, 2014
    Report Date
    June 16, 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 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: WERE CLIPS APPLIED TO VESSEL BUT FELL OFF AFTER HAVING BEEN APPLIED? IF CLIPS FELL OFF, WAS THERE ANY BLEEDING OR LEAK THAT OCCURRED? IF BLEEDING, PLEASE QUANTIFY AMOUNT OF BLEEDING THAT OCCURRED. WERE ANY BLOOD PRODUCTS GIVEN TO PATIENT? WAS THERE ANY CHANGE TO PROCEDURE OR POST-OP PATIENT CARE AS RESULT OF BLEEDING OR LEAK? HOW WAS CASE COMPLETED? IS DEVICE AVAILABLE TO RETURN FOR ANALYSIS? FROM CUSTOMER: THE CLIPS DID NOT PROPERLY CLAMP, THE TIPS CROSSED AND DID NOT HOLD. THERE WAS NO BLEEDING AT SITE, NO INJURY TO THE PT. NO BLOOD PRODUCTS GIVEN. A ANOTHER LIGACLIP WAS OPENED TO FINISH CASE.

    Description of Event or Problem · 1

    PLEASE SEE USER FACILITY MEDWATCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    390825 ROTATING MULTIPLE CLIP APPLIER CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR