BEUDAMED
    FDA Adverse Event Summary report: N

    INSERT, BIPOLAR FORCEPS

    MDR report key: 3981340 · Received July 25, 2014

    Report

    Report Number
    1418479-2014-00038
    Date Received
    July 25, 2014
    Report Date
    June 26, 2014
    Manufacturer
    RICHARD WOLF MEDICAL INSTRUMENTS CORP.
    Product Code
    GEI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION WAS COMPLETED ON 06/30/2014 AS THE ACTUAL DEVICE WAS RETURNED TO THE RWMIC FACULTY. SHAFT WAS BENT. DEVICE ON ITS OWN IS NOT CAPABLE OF PRODUCING ENOUGH ENERGY TO CAUSE A BURN. DEVICE HISTORY: SOLD DATE: (B)(4) 2013. NO RECORD OF ANY REPAIRS OR ROUTINE MAINTENANCE OF DEVICE. NO SIMILAR ISSUES REPORTED IN LAST THREE YEARS ALTHOUGH MANY DEVICES HAVE BEEN RETURNED TO BE REPAIRED DUE TO BEING BENT. ROOT CAUSE DUE TO HANDLING BY USER. RICHARD WOLF CONSIDERS THIS MATTER CLOSED. HOWEVER, IN THE EVENT WE RECEIVE ADDITIONAL INFORMATION, WE WILL PROVIDE FDA WITH FOLLOW-UP INFORMATION.

    Description of Event or Problem · 1

    CUSTOMER ORIGINALLY NOTIFIED RICHARD WOLF MEDICAL INSTRUMENTS CORP (RWMIC) TO REPORT THE GENERATOR WOULD ONLY PERFORM AT THE MAXIMUM LEVEL, NOT AT THE MINIMUM LEVEL. AFTER DEVICE WAS RECEIVED, A FOLLOW UP CALL REGARDING REPLACEMENT OF DEVICE WAS DONE. AT THAT TIME, ADDITIONAL INFORMATION WAS REPORTED, SYSTEM CAUSED A BURN. THE DEVICES BELOW COMBINE TO MAKE ONE SYSTEM, AND THESE WERE THE DEVICES BEING USED DURING THE PROCEDURE, THEY CONSIST OF THE FOLLOWING: GENERATOR (2352.011) REPORT 1418479-2014-00036, FORCEPS (8384.240) REPORT 1418479-2014-00037, JAW INSERT (8394.714) REPORT 1418479-2014-00038, FOOTSWITCH (2030.103), REPORT 1418479-2014-00039.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    437028 INSERT, BIPOLAR FORCEPS BIPOLAR FORCEPS GEI RICHARD WOLF MEDICAL INSTRUMENTS CORP. 8394.714 249L12

    Patients

    Seq Age Sex Outcome Treatment
    1 Other