BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RF SURGICAL

    MDR report key: 7026714 · Received November 13, 2017

    Report

    Report Number
    1717344-2017-06225
    Event Type
    Malfunction
    Date Received
    November 13, 2017
    Report Date
    December 11, 2017
    Manufacturer
    MITG - RF SURGICAL SYSTEMS
    Product Code
    LWH
    UDI-DI
    10884521700703
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: TO DATE, THE INCIDENT SAMPLE HAS NOT BEEN RECEIVED FOR EVALUATION. IF THE SAMPLE IS RECEIVED, OR IF ADDITIONAL INFORMATION PERTINENT TO THE INCIDENT IS OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: EVALUATION SUMMARY: ONE (B)(4) DEVICE WAS RECEIVED, AND EVALUATION OF THE UNIT COULD NOT CONFIRM THE CUSTOMER REPORTED CONDITION. THE VISUAL INSPECTION FOUND THE FRONT PANEL DAMAGED. THE INVESTIGATION IDENTIFIED A DIFFERENT FAULT BUT IT COULD NOT BE DETERMINED IF THIS WAS RELATED TO THE CUSTOMER REPORTED CONDITION. THE UNIT FAILED TO FULLY BOOT UP AND THE INVESTIGATION ISOLATED THE FAILURE TO A SOFTWARE ISSUE. THE ROOT CAUSE OF THE CONDITION WAS ISOLATED TO A CORRUPTED RECORD IN THE PATIENT-LOG.CSV FILE. THE SOFTWARE WAS RELOADED TO ADDRESS THE CONDITION. INTERNAL INSPECTION OF THE UNIT FOUND THE PRESENCE OF SOLID FERRITES ON BOTH THE RF MAT AND ACCESSORY PORT CIRCUITS. THESE HAVE BEEN SHOWN TO CAUSE INTERFERENCE WITH SCANS, AND HAVE BEEN REMOVED FROM THE DESIGN OF THE CONSOLE. THE UNIT WAS REPAIRED AND RETURNED TO THE CUSTOMER. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, THE UNIT'S SCAN DID NOT DETECT ANYTHING. A PATIENT WAS PRESENT BUT NO PATIENT INJURY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    804231 RF SURGICAL COUNTER, SPONGE, SURGICAL LWH MITG - RF SURGICAL SYSTEMS 01-0043 10884521700703

    Patients

    Seq Age Sex Outcome Treatment
    1