BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSERT, BIPOLAR FORCEPS

    MDR report key: 4669543 · Received April 2, 2015

    Report

    Report Number
    1418479-2015-00005
    Event Type
    Malfunction
    Date Received
    April 2, 2015
    Date of Event
    February 23, 2015
    Report Date
    March 10, 2015
    Manufacturer
    RICHARD WOLF MEDICAL INSTRUMENTS CORP.
    Product Code
    GEI
    PMA / PMN Number
    K981321
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION WAS COMPLETED AS THE ACTUAL DEVICE WAS RETURNED TO THE RWMIC FACILITY ON 03/13/2015. MECHANICAL ASSEMBLY MANAGER FOUND DEVICE SHOWED SIGNS OF WEAR AND WAS SENT TO A THIRD PARTY FOR REPAIRS. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE, I.E. INTENDED USE, INDICATIONS AND FIELD OF USE, PREPARATION AND CAUTIONS. REQUEST FOR ADDITIONAL INFORMATION SENT, ALL INFORMATION RECEIVED HAS BEEN ENTERED. RICHARD WOLF CONSIDERS THIS MATTER CLOSED. HOWEVER, IN THE EVENT WE RECEIVE ADDITIONAL INFORMATION, WE WILL PROVIDE FDA WITH FOLLOW-UP INFORMATION. K990147.

    Description of Event or Problem · 1

    RICHARD WOLF MEDICAL INSTRUMENT CORPORATION (RWMIC) WAS NOTIFIED BY FACILITY THAT AFTER FULGURATING TISSUE, THE TIP OF DEVICE IN QUESTION BECAME STUCK TO TISSUE. SLIGHT DELAY IN PROCEDURE IN ORDER TO DISLODGE DEVICE FROM TISSUE. THE ADDITIONAL TIME NEEDED MAY HAVE PLACED PATIENT AT RISK. NO INJURY TO PATIENT WAS REPORTED. FACILITY USED THREE DIFFERENT DEVICES DURING THE PROCEDURE BUT ARE UNSURE WHICH DEVICE ACTUALLY STUCK TO THE TISSUE, THE FOLLOWING ARE SUSPECT DEVICES: JAW INSERT (8393.714), REPORT 1418479-2015-00005; BIPOLAR FORCEPS (8383.240), REPORT 1418479-2015-00009; BIPOLAR FORCEPS (8383.211), REPORT 1418479-2015-00010.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    220362 INSERT, BIPOLAR FORCEPS FORCEPS GEI, HIN GEI RICHARD WOLF MEDICAL INSTRUMENTS CORP. 8393.714 249F12

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR