BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAMMOTOME REVOLVE CONTROL MODULE

    MDR report key: 7904267 · Received September 24, 2018

    Report

    Report Number
    3008492462-2018-00072
    Event Type
    Malfunction
    Date Received
    September 24, 2018
    Date of Event
    August 30, 2018
    Report Date
    August 30, 2018
    Manufacturer
    DEVICOR MEDICAL PRODUCTS, INC.
    Product Code
    KNW
    PMA / PMN Number
    K152989
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE MSCM1 (CONTROL MODULE) IS AN ELECTRONIC DEVICE THAT RUNS THE SOFTWARE NECESSARY TO OPERATE THE MAMMOTOME REVOLVE DUAL VACUUM-ASSISTED BIOPSY SYSTEM. THE DEVICE ALSO HOUSES THE VACUUM PUMP, POWER SUPPLY, VALVE ACTUATORS, USER TOUCHSCREEN INTERFACE AND CONTROL ELECTRONICS. THE DEVICE WAS RETURNED TO DEVICOR MEDICAL PRODUCTS INC. FOR EVALUATION. WHEN POWERED ON THE DEVICE WAS CONFIRMED TO HAVE A SMOKE ODOR. WHEN OPENED, THERE WAS EVIDENCE ON THE MAIN PCB BOARD INDICATIVE OF EXCESSIVE CURRENT DRAW FROM A SHORT CIRCUIT; 24V TO GROUND. IT IS NOT LIKELY THAT THIS SHORT CIRCUIT WOULD HAVE LED TO A FIRE IN THE DEVICE. A 24V SHORT TO GROUND HAS BEEN ASSESSED IN THE DFMEA AS A LOW RISK.

    Description of Event or Problem · 1

    DEVICOR MEDICAL PRODUCTS INC. RECEIVED A REPORT FROM AFFILIATE, (B)(4), STATING, "DURING INITIALIZING PROCESS, EVERYTHING WAS FINE. TWENTY MINUTES AFTER THE POWER WAS TURNED ON, SUDDENLY THERE WAS BURNING SOUND AND SMELL AND THE POWER WAS TURNED OFF". THERE WAS NO REPORT OF PATIENT OR USER INJURY. THIS HAS BEEN DOCUMENTED IN OUR COMPLAINT SYSTEM AS RECORD # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    742758 MAMMOTOME REVOLVE CONTROL MODULE BIOPSY INSTRUMENT KNW DEVICOR MEDICAL PRODUCTS, INC. MSCM1

    Patients

    Seq Age Sex Outcome Treatment
    1