BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RENEW ELECTROCAUTERY PROBE, 34 CM, REUSABLE

    MDR report key: 19353368 · Received May 20, 2024

    Report

    Report Number
    1223422-2024-00015
    Event Type
    Malfunction
    Date Received
    May 20, 2024
    Date of Event
    May 6, 2024
    Report Date
    May 20, 2024
    Manufacturer
    MICROLINE SURGICAL INC
    Product Code
    GEI
    UDI-DI
    00811099010913
    PMA / PMN Number
    K981188
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS DEVICE IS BEING SENT BACK TO MICROLINE SURGICAL, INC AND AN INVESTIGATION WILL BE CONDUCTED. A FINAL REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 0

    BURNED A PATIENT, RE-INSTALLED L-HOOK AND TIP WAS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1609417 RENEW ELECTROCAUTERY PROBE, 34 CM, REUSABLE ENDOSCOPIC ELECTROSURGICAL HANDPIECE/ELECTRODE, MONOPOLAR, REUSABLE GEI MICROLINE SURGICAL INC 6924 00169558 00811099010913

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown