BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KRONOS ELECTROCAUTERY DEVICE

    MDR report key: 25276634 · Received May 26, 2026

    Report

    Report Number
    25276634
    Event Type
    Malfunction
    Date Received
    May 26, 2026
    Date of Event
    May 5, 2026
    Report Date
    May 6, 2026
    Manufacturer
    SINGLE PASS, INC
    Product Code
    GEI
    UDI-DI
    00860008582300
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE STYLET OF THE ELECTROCAUTERY DEVICE WAS BENT WITHIN THE PACKAGING. SUBSEQUENTLY, WHILE RETRACTING THE DEVICE AS IT WAS BEING REMOVED, THE STYLET REMAINED IN PLACE AND THE WIRING FROM WITHIN THE DEVICE BECAME EXPOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    102091 KRONOS ELECTROCAUTERY DEVICE ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI SINGLE PASS, INC 900001SP-02 030426C 00860008582300

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other