BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRYO - SURGICAL DEVICE

    MDR report key: 12358660 · Received August 24, 2021

    Report

    Report Number
    1316297-2021-00001
    Event Type
    Malfunction
    Date Received
    August 24, 2021
    Date of Event
    January 19, 2021
    Report Date
    June 1, 2021
    Manufacturer
    EPIMED
    Product Code
    GXH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EPIMED REACHED OUT TO (B)(4) WHO INITIALLY COMPLETED THE MEDWATCH FDA FORM. (B)(4) IS REPORTED TO BE OUT OF OFFICE UNTIL SEPTEMBER 2021. EPIMED REACHED OUT TO (B)(4), BIOMED AT(B)(4), WHO REPORTED HE BELIEVED THE ISSUE WITH THE CRYO CONSOLE HAD BEEN FIXED AT THEIR ACCOUNT, WHEN A CABLE WAS SWITCHED OUT FROM THE CRYO CONSOLE. EPIMED FURTHERMORE REACHED OUT TO (B)(4), PATIENT SAFETY AT (B)(4), WHO ALSO REPORTED THAT SHE BELIEVED THE CRYO CONSOLE HAD BEEN FIXED AT THEIR ACCOUNT. BOTH (B)(4) WERE UNAWARE THAT A MEDWATCH FDA FORM WAS BEING COMPLETED AND SENT TO EPIMED. NO OTHER INFORMATION HAS BEEN PROVIDED REGARDING THE STATE OF THE CONSOLE OR THE HEALTH STATUS OF THE PATIENT INVOLVED. ANY NEW INFORMATION WILL BE REPORTED.

    Description of Event or Problem · 1

    IN REFERENCE TO FDA REPORT NUMBER (B)(4), DURING A CRYOABLATION, THE CURRENT KNOB WAS BEING TURNED COUNTERCLOCKWISE DOWN TO ZERO. RIGHT AT THE ZERO POINT, THE CURRENT WENT TO 100, GIVING THE PATIENT A NOTICEABLE SHOCK. THE PATIENT HAS SINCE HAS PERSISTENT PAIN AND REQUIRED ADDITIONAL OCCIPITAL NERVE BLOCKS TO DECREASE THE NERVE PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1260545 CRYO - SURGICAL DEVICE CRYO PAIN BLOCKER CONSOLE GXH EPIMED

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Other