BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FOOTSWITCH FOR USE W/ 2352.011

    MDR report key: 3982778 · Received July 25, 2014

    Report

    Report Number
    1418479-2014-00039
    Event Type
    Injury
    Date Received
    July 25, 2014
    Report Date
    June 26, 2014
    Manufacturer
    RICHARD WOLF GMBH
    Product Code
    GEI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    MN, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    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 INFO 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. AN INVESTIGATION WAS COMPLETED ON (B)(6) 2014 AS THE ACTUAL DEVICE WAS RETURNED TO THE RWMIC FACILITY. HOUSING WAS BROKEN BUT UNIT WAS STILL FUNCTIONAL, ROOT CAUSE IS WEAR AND TEAR. MFR DATE: (B)(4) 2007, SOLD ATE: (B)(4) 2007. NO RECORD OF ANY REPAIRS OR ROUTINE MAINTENANCE OF DEVICE. NO SIMILAR ISSUES REPORTED IN THE LAST THREE YEARS. RICHARD WOLF CONSIDERS THIS MATTER CLOSED. HOWEVER, IN THE EVENT WE RECEIVED ADDITIONAL INFO, WE WILL PROVIDE FDA WITH FOLLOW-UP INFO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    436985 FOOTSWITCH FOR USE W/ 2352.011 FOOTSWITCH GEI RICHARD WOLF GMBH 2030.103 01553

    Patients

    Seq Age Sex Outcome Treatment
    1 Other