BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WORKING ELEMENT

    MDR report key: 3850772 · Received March 21, 2014

    Report

    Report Number
    1418479-2014-00011
    Event Type
    Malfunction
    Date Received
    March 21, 2014
    Date of Event
    February 1, 2014
    Report Date
    February 20, 2014
    Manufacturer
    RICHARD WOLF MEDICAL INSTRUMENTS CORP.
    Product Code
    FDC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION WAS COMPLETED AS THE ACTUAL DEVICE WAS RETURNED TO THE RWMIC FACILITY ON (B)(4) 2014. MECHANICAL ASSEMBLY MANAGER FOUND THE SHAFT WAS BENT, MOST LIKELY DUE TO HANDLING OVER TIME. NO ISSUES FOUND TO CAUSE DEVICE TO START AND STOP FUNCTIONING. DEVICE LAST IN FOR REPAIR AND/OR MAINTENANCE ON 06/13/2012. DEVICE WAS USED IN CONJUNCTION WITH A COMPETITOR'S GENERATOR AND BIPOLAR CABLE. RWMIC INSTRUCTION MANUAL INDICATES "USE THE PRODUCT ONLY IN THE COMBINATIONS AND WITH THE ACCESSORIES AND SPARE PARTS SPECIFIED IN THIS INSTRUCTION MANUAL," AND THIS COMPETITOR'S DEVICES ARE NOT LISTED IN THE MANUAL. 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 INFORMATION, WE WILL PROVIDE THE FDA WITH FOLLOW-UP INFORMATION.

    Description of Event or Problem · 1

    DEVICE WORKED ON AND OFF DURING PROCEDURE. NO INJURY TO PATIENT OR STAFF REPORTED; HOWEVER, CASE WAS STOPPED AND RESCHEDULED FOR A LATER DATE. TWO DEVICES WITH THE SAME LOT NUMBER WERE IN OR ROOM BUT ONLY ONE WAS USED, THE OTHER RETURNED FOR EVALUATION. MDR REPORT COMPLETED FOR BOTH DEVICES. MDR 1418479-2014-00010, MDR 1418479-2014-00011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    170351 WORKING ELEMENT FDC RICHARD WOLF MEDICAL INSTRUMENTS CORP. 8680.224 M1011047

    Patients

    Seq Age Sex Outcome Treatment
    1