BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RF SURGICAL

    MDR report key: 6919051 · Received October 5, 2017

    Report

    Report Number
    3005883396-2017-05086
    Event Type
    Malfunction
    Date Received
    October 5, 2017
    Date of Event
    July 28, 2017
    Report Date
    September 8, 2017
    Manufacturer
    MITG - RF SURGICAL SYSTEMS
    Product Code
    LWH
    PMA / PMN Number
    K062642
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE DEVICE SCANNER HAD AN ISSUE WITH FALSE POSITIVE TONES. IT WOULD CONTINUALLY INDICATE THAT A SPONGE WAS PRESENT. THE ISSUE WAS RESOLVED BY REPLACING THE WAND, AND THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    694488 RF SURGICAL COUNTER, SPONGE, SURGICAL LWH MITG - RF SURGICAL SYSTEMS 01-0035

    Patients

    Seq Age Sex Outcome Treatment
    1