BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BAYLIS MEDICAL COMPANY RADIOFREQUENCY PUNCTURE GENERATOR

    MDR report key: 16358174 · Received February 10, 2023

    Report

    Report Number
    3019751610-2023-00021
    Event Type
    Malfunction
    Date Received
    February 10, 2023
    Date of Event
    January 11, 2023
    Report Date
    February 10, 2023
    Manufacturer
    BAYLIS MEDICAL COMPANY INC.
    Product Code
    GEI
    UDI-DI
    00685447000969
    PMA / PMN Number
    K122278
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THERE WAS NO PATIENT OR USER IMPACT. THE INVESTIGATION ON THE MALFUNCTION OF THE DEVICE IS ONGOING. BASED ON THE INFORMATION REPORTED, BAYLIS MEDICAL COMPANY INC. HAS DECIDED TO REPORT THIS EVENT. A DHR REVIEW WAS COMPLETED, AND THE DEVICE FULFILLED ALL REQUIREMENTS PRIOR TO RELEASE.

    Description of Event or Problem · 0

    DURING THE PROCEDURE, THE PHYSICIAN WITNESSED SPARKS RELATED TO THE BAYLIS MEDICAL COMPANY RADIOFREQUENCY PUNCTURE GENERATOR. THE GENERATOR CEASED OPERATION LEADING TO A 20-MINUTE PROCEDURAL DELAY. AS A RESULT, A MECHANICAL NEEDLE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO IMPACT TO THE PATIENT OR USER. WHILE THERE WAS NO PATIENT OR USER INJURY REPORTED, BAYLIS MEDICAL COMPANY INC. HAS DECIDED TO REPORT THIS EVENT DUE TO THE MALFUNCTION OF THE BAYLIS MEDICAL COMPANY RADIOFREQUENCY PUNCTURE GENERATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    47689 BAYLIS MEDICAL COMPANY RADIOFREQUENCY PUNCTURE GENERATOR RADIOFREQUENCY GENERATOR GEI BAYLIS MEDICAL COMPANY INC. RFP-100A 00685447000969

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other