BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACE

    MDR report key: 23402113 · Received October 28, 2025

    Report

    Report Number
    23402113
    Event Type
    Malfunction
    Date Received
    October 28, 2025
    Date of Event
    September 15, 2025
    Report Date
    September 23, 2025
    Manufacturer
    ACE MEDICAL DEVICES PRIVATE LIMITED
    Product Code
    FAS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    ULTRATHIN LOOP BROKE AT THE SIDE OF THE LOOP DURING USE IN TURBT [TRANSURETHRAL RESECTION OF BLADDER TUMOR].

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2352145 ACE ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL FAS ACE MEDICAL DEVICES PRIVATE LIMITED LPS-12T-QFM TL44203

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown