BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LSEN RESECTOSCOPE INTERUMENT CONNECTOR

    MDR report key: 3612544 · Received December 6, 2013

    Report

    Report Number
    1530493-2013-00004
    Event Type
    Malfunction
    Date Received
    December 6, 2013
    Date of Event
    October 18, 2013
    Report Date
    December 3, 2013
    Manufacturer
    OLSEN MEDICAL
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS REPORTED AS AN ADVERSE EVENT, (B)(4), ON (B)(6) 2013 BY (B)(6). THE TYPE OF PROCEDURE THE DEVICE WAS USED IN WAS NOT KNOWN. THE INSTRUMENT WAS NOT RETURNED FOR EVAL. THE COMPLAINT CANNOT BE VERIFIED.

    Description of Event or Problem · 1

    THE END OF THE DEVICE WAS LOOSEN ON THE TVR CONNECTOR CORD AND THEREFORE, COULD NOT BE USED. DEVICE USAGE PROBLEM CODE: DEVICE MALFUNCTION, FAILED, COULD NOT GET IT TO WORK, DID NOT DO WHAT THE DEVICE WAS INTENDED TO DO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    634919 LSEN RESECTOSCOPE INTERUMENT CONNECTOR SINGLE USE MONOPOLAR CABLE GEI OLSEN MEDICAL 92002 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other