BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TUBE, OUTER, BIOPOLAR FORCEPS

    MDR report key: 3970105 · Received April 29, 2014

    Report

    Report Number
    1418479-2014-00004
    Event Type
    Malfunction
    Date Received
    April 29, 2014
    Date of Event
    January 1, 2014
    Report Date
    January 17, 2014
    Manufacturer
    RICHARD WOLF MEDICAL INSTRUMENTS CORP.
    Product Code
    GEI
    Report Source
    Manufacturer 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. NO ISSUES FOUND THE DEVICE. DEVICE HISTORY: SOLD ON (B)(4) 2000 NO RECORD OF ANY REPAIRS OR ROUTINE MAINTENANCE OF DEVICE. NO SIMILAR ISSUES REPORTED IN THE 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 RECEIVE ADDITIONAL INFO, WE WILL PROVIDE FDA WITH FOLLOW-UP INFO.

    Description of Event or Problem · 1

    RICHARD WOLF MEDICAL INSTRUMENT CORP (RWMIC) WAS NOTIFIED BY FACILITY THAT DURING A TUBAL LIGATION, THE FORCEPS INSERT WAS PLACED AROUND FALLOPIAN TUBE AND BECAME STUCK. SLIGHTLY 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), REPORT 1418479-2014-00003; OUTER TUBE (8393.925), REPORT 1418479-2014-00004; SLEEVE (8393.923), REPORT 1418479-2014-00005; FORCEP INSERT (8383.211), REPORT 1418479-2014-00006.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    255502 TUBE, OUTER, BIOPOLAR FORCEPS OUTER TUBE GEI RICHARD WOLF MEDICAL INSTRUMENTS CORP. 8393.925 M237260

    Patients

    Seq Age Sex Outcome Treatment
    1