BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SANARUS VISICA TREATMENT SYSTEM

    MDR report key: 495326 · Received November 10, 2003

    Report

    Report Number
    3003515897-2003-00007
    Event Type
    Malfunction
    Date Received
    November 10, 2003
    Date of Event
    July 21, 2003
    Report Date
    November 7, 2003
    Manufacturer
    SANARUS MEDICAL, INC.
    Product Code
    GEH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE PHYSICIAN ATTEMPTED TREATMENT OF A FIBROADENOMA WITH THE VISICA TREATMENT SYSTEM. FOLLOWING PROGRAMMING OF THE TREATMENT ALGORITHM AND PRE-TEST, THE TIMER DISPLAY JUMPED TO A TIME GREATER THAN THAT PROGRAMMED. MANUAL MANIPULATION OF THE TIMER WAS REQUIRED TO TOGGLE TIME FOR THE CORRECT TREATMENT EXPOSURE. THIS MITIGATION IS ADDRESSED IN THE PRODUCT INSTRUCTIONS FOR USE. TREATMENT WAS SUCCESSFULLY COMPLETED AND THERE WAS NO PATIENT INCIDENT RELATED TO THIS MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SANARUS VISICA TREATMENT SYSTEM CRYOABLATION SYSTEM GEH SANARUS MEDICAL, INC. VS2000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention