BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN ENDO CLIP APPLIER

    MDR report key: 3122553 · Received May 17, 2013

    Report

    Report Number
    1219930-2013-00350
    Event Type
    Injury
    Date Received
    May 17, 2013
    Report Date
    April 26, 2013
    Manufacturer
    COVIDIEN, FORMERLY US SURGICAL
    Product Code
    FZP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: LAPAROSCOPIC CHOLECYSTECTOMY. ACCORDING TO THE REPORTER: DURING THE CASE, THE CLIP APPLIER WAS TAKEN FROM PACKAGE AND TWO CLIPS WERE PLACED ON THE PT'S SIDE ARTERY AT THIS THE CLIPS APPEARED TO BE NORMAL. NO THE THIRD PLACEMENT THE CLIP CROSSED TO PARTIAL CLOSURE AND THEN LOCKED/JAMMED. THE APPLICATOR WAS REMOVED OFF OF THE CLIP OK, BUT SINCE THE JAWS WERE LOCKED THE APPLICATOR HAD TO BE REMOVED FROM THE ABDOMEN ALONG WITH THE 5MM PORT. A NEW 5MM PORT AND A NEW DEVICE WAS OPENED AND INSERTED. TWO CLIPS WERE PLACED ON SPECIMEN SIDE. THEN TWO CLIPS WERE PLACED ON THE PT SIDE AND TWO MORE ON THE SPECIMEN SIDE. THE SURGEON STARTED TO DISSECT THE ARTERY AND ARTERY STARTED BLEEDING THROUGH THE TWO INITIAL CLIPS PLACED. BLEEDING COULD NOT BE CONTROLLED SO THE PROCEDURE WAS CONVERTED TO OPEN. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. APPROX 150CC BLOOD LOSS OCCURRED AND LAPAROTOMY SCARE DUE TO OPEN PROCEDURE. THERE WAS NO BLOOD TRANSFUSION REQUIRED. SURGERY WAS EXTENDED BY MORE THAN 30 MINUTES. COMORBIDITY ASSOCIATED TO LAPAROSCOPIC SURGERY. PT IS WELL AND HAS BEEN DISCHARGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    219515 UNKNOWN ENDO CLIP APPLIER DISPOSABLE CLIP APPLIER FZP COVIDIEN, FORMERLY US SURGICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR