BEUDAMED
    FDA Adverse Event Summary report: N

    FORCEPS, WAVE SIDE GRASPER

    MDR report key: 3912407 · Received June 27, 2014

    Report

    Report Number
    1418479-2014-00033
    Date Received
    June 27, 2014
    Date of Event
    April 11, 2014
    Report Date
    June 2, 2014
    Manufacturer
    RICHARD WOLF GMBH
    Product Code
    GCJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS INVESTIGATION WAS NOT COMPLETED AS THE ACTUAL DEVICE WAS NOT RETURNED TO THE MANUFACTURING FACILITY AS OF (B)(4) 2014. (B)(4). NO RECORD OF ANY ROUTINE MAINTENANCE OR REPAIRS SINCE PURCHASE. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. I.E., INTENDED USE, INDICATIONS AND FIELD OF USE, PREPARATION AND CAUTIONS. RICHARD WOLF CONSIDERS THIS MATTER CLOSED. HOWEVER, IN THE EVENT WE RECEIVE ADDITIONAL INFO, WE WILL PROVIDE FDA WITH FOLLOW-UP INFO.

    Description of Event or Problem · 1

    PROCEDURE: LAPAROSCOPIC SIGMOID COLECTOMY. DURING PROCEDURE A PIECE OF THE DEVICE BROKE OFF INSIDE THE ABDOMINAL CAVITY. X-RAYS TAKEN AND ADDITIONAL INCISION MADE TO RETRIEVE FOREIGN BODY. DELAY IN PROCEDURE IN ORDER TO RETRIEVE FOREIGN BODY. OUTSIDE OF THE ADDITIONAL INCISION MADE, NO ADDITIONAL INJURIES TO PATIENT OR STAFF REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    376350 FORCEPS, WAVE SIDE GRASPER FORCEPS GCJ RICHARD WOLF GMBH 83932936

    Patients

    Seq Age Sex Outcome Treatment
    1 Other