BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TIP, PYRAMIDAL, ART TROCAR, 5MM

    MDR report key: 3150251 · Received May 29, 2013

    Report

    Report Number
    9611102-2013-00002
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    February 11, 2013
    Report Date
    March 20, 2013
    Manufacturer
    RICHARD WOLF GMBH
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FULL INVESTIGATION COULD NOT BE COMPLETED AS THE ACTUAL DEVICE WAS NOT RETURNED TO THE RICHARD WOLF (B)(4) FACILITY AS OF ON 05/28/2013. REQUEST TO RETURN DEVICE OR SEND PHOTOS OF DEVICE FOR EVALUATION HAVE BEEN SUBMITTED. THE SHAFT IS SCREWED INTO THE BUTTON AND THE TWO ARE WELDED TOGETHER TO FORM A TROCAR. TRENDING RESULTS REVEALED NO SIMILAR OCCURRENCES HAVE BEEN REPORTED IN THE LAST FIVE YEARS. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. IE INTENDED USE, INDICATIONS AND FIELD OF USE, PREPARATION AND CAUTIONS. RICHARD WOLF CONSIDERS THIS MATTER CLOSED. HOWEVER, IN THE EVENT ADDITIONAL INFORMATION IS RECEIVED, WE WILL PROVIDED FDA WITH FOLLOW-UP INFORMATION.

    Description of Event or Problem · 1

    (B)(6) TRANSLATION OF (B)(6) REPORT: DURING A COELIOSKOPIE, THE HEAD OF THE TROCAR HAS BEEN SOLVED FROM THE ROD AND SLID INTO THE BODY VIA TROCAR SLEEVE. A PATIENT INJURY WAS NOT REPORTED. (B)(6) TRANSLATION OF (B)(6) REPORT: DURING A LAPAROSCOPIC SURGEON INTRODUCED A TROCAR SHEATH USING THE TROCAR (IS A BUTTON AND A ROD) THE BUTTON IS UNSCREWED AND THE TROCAR HAS SLIPPED INTO THE PERITONEUM. NO INJURY TO PATIENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    233599 TIP, PYRAMIDAL, ART TROCAR, 5MM TROCAR GCJ RICHARD WOLF GMBH 8921.123

    Patients

    Seq Age Sex Outcome Treatment
    1 Other