BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANDLE, SPRING STYLE

    MDR report key: 3800616 · Received April 29, 2014

    Report

    Report Number
    1418479-2014-00003
    Event Type
    Malfunction
    Date Received
    April 29, 2014
    Date of Event
    January 1, 2014
    Report Date
    January 17, 2014
    Manufacturer
    RICHARD WOLF GMBH
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION WAS COMPLETED AS THE ACTUAL DEVICE WAS RETURNED TO THE RWMIC FACILITY ON (B)(4) 2014. DEVICE HISTORY: SOLD ON (B)(4) 2000 NO RECORD OF ANY REPAIRS OR ROUTINE MAINTENANCE OF DEVICE. NO ISSUES FOUND WITH DEVICE. NO SIMILAR ISSUES REPORTED IN LAST THREE 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 WE RECEIVED ADDITIONAL INFORMATION, WE WILL PROVIDE FDA WITH FOLLOW-UP INFORMATION.

    Description of Event or Problem · 1

    RICHARD WOLF MEDICAL INSTRUMENT CORPORATION (RWMIC) WAS NOTIFIED BY FACILITY THAT DURING A TUBAL LIGATION, THE FORCEPS INSERT WAS PLACED AROUND FALLOPIAN TUBE AND BECAME STUCK. SLIGHT DELAY IN PROCEDURE IN ORDER TO DISLODGE DEVICE FROM FALLOPIAN TUBE. THE ADDITIONAL TIME NEEDED MAY HAVE PLACED PT AT RISK. NO INJURY TO PT, OTHER THAN THE PLANNED TUBAL LIGATION, WAS REPORTED. FOUR DEVICES COMBINE TO MAKE ONE SYSTEM USED DURING THE PROCEDURE, THEY CONSIST OF THE FOLLOWING: HANDLE (8393.975) - (B)(4); OUTER TUBE (8393.925) - REPORT (B)(4); SLEEVE (8393.923) - REPORT (B)(4); FORCEP INSERT (8383.211) - REPORT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    256614 HANDLE, SPRING STYLE HANDLE GEI RICHARD WOLF GMBH 8393.975 M253460

    Patients

    Seq Age Sex Outcome Treatment
    1