BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPERA STAR

    MDR report key: 243802 · Received October 4, 1999

    Report

    Report Number
    2952494-1999-00016
    Event Type
    Malfunction
    Date Received
    October 4, 1999
    Report Date
    November 13, 1998
    Manufacturer
    FEM RX
    Product Code
    FDC
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A GYN PROCEDURE, THE WIRE BROKE ON THE RESECTOSCOPE. PROCEDURE WAS COMPLETED. NO FURTHER PT CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPERA STAR RESECTOSCOPE FDC FEM RX NA 102197

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN