BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUTTING LOOP

    MDR report key: 424958 · Received October 25, 2002

    Report

    Report Number
    1519132-2002-00068
    Event Type
    Malfunction
    Date Received
    October 25, 2002
    Date of Event
    September 24, 2002
    Report Date
    October 23, 2002
    Manufacturer
    ACMI NORWALK
    Product Code
    KNS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    "WIRE BROKE OFF LOOP INSIDE THE PATIENT ON THE 1ST PASS. SECOND TIME THIS HAPPENED IN A WEEK WITH A MLE-26-012."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CUTTING LOOP * KNS ACMI NORWALK MLE-26-012 *

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN