BEUDAMED
    FDA Adverse Event Summary report: N

    FORCEPS, WAVE SIDE GRASPER

    MDR report key: 4360657 · Received December 19, 2014

    Report

    Report Number
    9611102-2014-00017
    Date Received
    December 19, 2014
    Date of Event
    November 3, 2014
    Report Date
    November 6, 2014
    Manufacturer
    RICHARD WOLF GMBH
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION WILL BE COMPLETED AS THE ACTUAL DEVICE WILL BE RETURNED TO (B)(4). (B)(4) DEVICES (ID# 83932936, LOT# 1105153) WERE SOLD TO USER FACILITY ON (B)(4) 2011. NO RECORD OF ANY ROUTINE MAINTENANCE OR REPAIRS SINCE PURCHASES. A REQUEST FOR ADDITIONAL INFO HAS BEEN SUBMITTED TO FACILITY FROM RWMIC, NO RESPONSE AS OF 12/03/2014. THE LOT 1105153 CONTAINS (B)(4) FORCEPS. UNTIL NOW, NO COMPLAINTS WERE NOTIFIED FROM THIS LOT. (B)(4) CONSIDERS THIS MATTER OPEN. ONCE DEVICE IS RECEIVED BY (B)(4) AND INVESTIGATION IS COMPLETE, A FOLLOW UP REPORT WILL BE SENT TO FDA.

    Description of Event or Problem · 1

    RICHARD WOLF, (B)(4) WAS NOTIFIED BY RICHARD WOLF MED INSTRUMENTS CORP USA (WRMIC) OF A BREAK OF A FORCEPS ID# 83932936. RICHARD WOLF MED INSTRUMENTS CORP (RWMIC) WAS NOTIFIED THAT DURING A PROCEDURE A PIECE OF THE DEVICE BROKE OFF INSIDE THE PT. A SEARCH FOR THE FOREIGN OBJECT WAS PERFORMED; HOWEVER, IT WAS NOT FOUND. AN X-RAY WAS PERFORMED AND FOREIGN OBJECT REMAINS IN PT. FACILITY HAD BACKUP DEVICE AVAILABLE AND WAS ABLE TO COMPLETE THE PROCEDURE. NO INJURIES TO PT OR STAFF WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    838192 FORCEPS, WAVE SIDE GRASPER GCJ RICHARD WOLF GMBH 83932936 1105153

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR