BEUDAMED
    FDA Adverse Event Summary report: N

    OPERA STAR

    MDR report key: 243626 · Received October 4, 1999

    Report

    Report Number
    2952494-1999-00004
    Date Received
    October 4, 1999
    Report Date
    November 21, 1997
    Manufacturer
    FEM RX
    Product Code
    FDC
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE WIRE BROKE ON THE RESECTOR. THE PROCEDURE WAS HALTED. ADDITIONALLY, THE PT EXHIBITED A 1 LITER FLUID DEFICIT, BUT THIS WAS NOT RELATED TO THE PRODUCT EVENT. NO ADVERSE PT CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPERA STAR RESECTOSCOPE FDC FEM RX NA 092997

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN