BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PMI LLETZ LOOP 20MMX 12MM, 13CM

    MDR report key: 15633112 · Received October 18, 2022

    Report

    Report Number
    MW5112737
    Event Type
    Malfunction
    Date Received
    October 18, 2022
    Date of Event
    October 13, 2022
    Report Date
    October 17, 2022
    Manufacturer
    PROGRESSIVE MEDICAL INC.
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    DURING OUR PROCEDURE ( LOOP ELECTRODE EXCISION PROCEDURE) THE ELECTRICAL LOOP USED DISINTEGRADED AND BROKE OFF INSIDE THE PATIENTS CERVIX. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2820815 PMI LLETZ LOOP 20MMX 12MM, 13CM ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI PROGRESSIVE MEDICAL INC. 200902 2009049

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Female