BEUDAMED
    FDA Adverse Event Death Summary report: N

    ROTATING MULTIPLE CLIP APPLIER

    MDR report key: 3181737 · Received June 21, 2013

    Report

    Report Number
    3005075853-2013-03183
    Event Type
    Death
    Date Received
    June 21, 2013
    Date of Event
    April 24, 2013
    Report Date
    May 30, 2013
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    FZP
    PMA / PMN Number
    K864102
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE WAS NOT RETURNED FOR EVALUATION. ATTEMPTS ARE BEING MADE TO OBTAIN ADDITIONAL INFORMATION AND COORDINATE A CALL WITH THE OPERATING SURGEON AND ETHICON. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. WAS THE CLIP FULLY ADVANCED INTO THE JAWS PRIOR TO FIRING? WAS THERE ANY TORQUE OR TWISTING OF THE DEVICE PRESENT AT THE TIME OF FIRING? WAS ANY UNEXPECTED RESISTANCE FELT WHILE FIRING THE TRIGGER? DID ANYTHING UNEXPECTED HAPPEN PRIOR TO THIS INCIDENT? WHAT TYPE OF CAUTERY WAS USED? WAS THE PATIENT STILL IN THE HOSPITAL, OR HAD THE PATIENT BEEN DISCHARGED AND READMITTED? WAS A REOPERATION PERFORMED? WAS THE SOURCE OF BLEEDING IDENTIFIED? WHAT MEASURES WERE TAKEN TO CONTROL THE BLEEDING, IF ANY? DID THEY OBSERVE THE CLIP(S) AT REOPERATION OR AUTOPSY? IF SO, WHAT WAS THE FORMATION OF THE CLIPS? WAS AN AUTOPSY PERFORMED? WHAT WAS THE CAUSE OF DEATH? DID THE PATIENT HAVE ANY BLEEDING ISSUES (MEDICATIONS ¿ PLAVIX, COUMADIN, ETC¿)? ANY OTHER MEDICAL ISSUES THAT CONTRIBUTED TO THE DEATH (EX. MI CAUSED BY BLEEDING¿)? 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 DEVICE WAS FIRED ACROSS THE CYSTIC ARTERY THERE WAS A SMALL BLEEDER HALF WAY UP THE LIVER BED THAT WAS CONTROLLED WITH CLIPS AND CAUTERY. A JACKSON-PRATT DRAIN WAS PLACED. THE PROCEDURE WAS COMPLETED AND LATER THAT DAY THE PATIENT EXPIRED DUE TO BLOOD LOSS. THE CUT TIME OF THE PROCEDURE WAS 0756AM AND THE PATIENT EXPIRED 2135PM THE SAME DAY. THE DEVICE WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283280 ROTATING MULTIPLE CLIP APPLIER CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Death