BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BAYLIS MEDICAL COMPANY RADIOFREQUENCY PUNCTURE GENERATOR

    MDR report key: 11752675 · Received April 30, 2021

    Report

    Report Number
    9710452-2021-00026
    Event Type
    Malfunction
    Date Received
    April 30, 2021
    Date of Event
    March 31, 2021
    Report Date
    April 30, 2021
    Product Code
    GEI
    PMA / PMN Number
    K122278
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO PATIENT IMPACT OR CONSEQUENCE. BAYLIS MEDICAL COMPANY INC. HAS DECIDED TO REPORT THIS EVENT DUE TO THE PROCEDURAL DELAY THAT OCCURRED . DHR REVIEW WAS COMPLETED AND THE GENERATOR PASSED ALL FINAL TESTS PRIOR TO RELEASE.

    Description of Event or Problem · 1

    A 30-MINUTE PROCEDURAL DELAY WAS REPORTED DUE TO MALFUNCTION OF THE BAYLIS RADIOFREQUENCY PERFORATION GENERATOR AFTER IT WAS TURNED ON. THE GENERATOR WAS TURNED OFF AND THE INSPECTION REVEALED THAT THE GROUND WIRE INSIDE THE DEVICE HAD BECOME DISCONNECTED. THE PROCEDURE WAS RESUMED WITHOUT ANY INCIDENTS AFTER THE WIRE WAS RECONNECTED. WHILE THERE WAS NO PATIENT INJURY REPORTED, BAYLIS MEDICAL COMPANY INC. HAS DECIDED TO REPORT THIS EVENT DUE TO THE PROCEDURAL DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    653058 BAYLIS MEDICAL COMPANY RADIOFREQUENCY PUNCTURE GENERATOR RADIOFREQUENCY GENERATOR GEI RFP-100A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other