BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RENEW XR HANDPIECE, 34CM

    MDR report key: 19353023 · Received May 20, 2024

    Report

    Report Number
    1223422-2024-00016
    Event Type
    Malfunction
    Date Received
    May 20, 2024
    Date of Event
    May 15, 2024
    Report Date
    May 20, 2024
    Manufacturer
    MICROLINE SURGICAL INC
    Product Code
    GEI
    UDI-DI
    00811099013761
    PMA / PMN Number
    K234147
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    (B)(6) HOSPITAL IN (B)(6) , RI EXPERIENCED AN ELETRCIAL ARCING INCIDENT WHILE USING THE MONOPOLAR FUNCTION OF A MICROLINE XR HANDPIECE, AND A MICROLINE SCISSOR TIP. THE HANDPIECE, AND SCISSOR TIP HAVE BEEN RETRIEVED AND SENT BACK TO MICROLINE SURGICAL HEADQUARTERS FOR FURTHER INVESTIGATION. MONOPOLAR SETTINGS USED INSIDE OF THE PATIENT WERE 60/40, AND THEN 35/45. STAFF ATTHE FACILITY STATED THAT THE PATIENT WASN'T HARMED, HOWEVER THE INSTRUMENT DID ARC WHILE INSIDE THE PATIENT CAVITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1606766 RENEW XR HANDPIECE, 34CM ENDOSCOPIC ELECTROSURGICAL HANDPIECE, ELECTRODE/MONOPOLAR/REUSABLE GEI MICROLINE SURGICAL INC 3941 00171665 00811099013761

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown