BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO CLIP APPLIER

    MDR report key: 3911555 · Received June 26, 2014

    Report

    Report Number
    1219930-2014-00483
    Event Type
    Injury
    Date Received
    June 26, 2014
    Report Date
    May 29, 2014
    Manufacturer
    COVIDIEN LP, FORMERLY REGISTERED AS UNITED STATES SURGICAL
    Product Code
    FZP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE: LAP APPENDECTOMY. ACCORDING TO THE REPORTER: IN AN ARTICLE ENTITLED "COMPARISON OF INTRACORPOREAL KNOT-TYING SUTURE (POLYGLACTIN) AND TITANIUM ENDOCLIPS IN LAPAROSCOPIC APPENDICAL STUMP CLOSURE: A PROSPECTIVE RANDOMIZED STUDY" WRITTEN BY MUSTAFA ATES ET AL. PUBLISHED IN SUG LAPAROSC ENDOSC PERCUTAN TECH, VOLUME 22, NUMBER 3, JUNE 2012, A PROSPECTIVE STUDY WAS CONDUCTED FROM APRIL 2010 TO FEBRUARY 2011. 61 PATIENTS UNDERWENT A LAPAROSCOPIC APPENDECTOMY. THESE PATIENTS WERE DIVIDED INTO TWO GROUPS: TITANIUM ENDOCLIP AND KNOT-TYING (POLYGLACTIN). IN THE ENDOCLIP GROUP, ONE PATIENT PRESENTED WITH ABDOMINAL PAIN ON POSTOPERATIVE DAY 3 BASED ON AN ABDOMINAL X-RAY SHOWING 2 OPEN TITANIUM CLIPS IN THE PELVIC AREA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    373006 ENDO CLIP APPLIER END CLIP APPLIER FZP COVIDIEN LP, FORMERLY REGISTERED AS UNITED STATES SURGICAL

    Patients

    Seq Age Sex Outcome Treatment
    1