BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OCUTOME

    MDR report key: 13010 · Received April 29, 1994

    Report

    Report Number
    MW1001786
    Event Type
    Malfunction
    Date Received
    April 29, 1994
    Manufacturer
    ALSON SURGICAL, INC.
    Product Code
    HQE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT WAS UNDER GENERAL ANESTHESIA FOR VITRECTOMY, WHEN THE MEDICAL DEVICE STOPPED WORKING. THE SURGEON AND THE MEDICAL STAFF COULD NOT CORRECT THE PROBLEM, AND THE SURGERY HAD TO BE STOPPED, MID-PROCEDURE. THE PT WAS RECOVERED AND TRANSFERRED TO ANOTHER HOSP TO COMPLETE THE PROCEDURE. NO ADVERSE OUTCOME KNOWN AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCUTOME SURGICAL EYE INSTRUMENT HQE ALSON SURGICAL, INC. STTO NA

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other