BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WET-FIELD HEMOSTATIC ERASER

    MDR report key: 2036937 · Received March 22, 2011

    Report

    Report Number
    2036937
    Event Type
    Malfunction
    Date Received
    March 22, 2011
    Date of Event
    January 13, 2011
    Report Date
    March 22, 2011
    Manufacturer
    MEDTRONIC OPHTHALMICS
    Product Code
    HQR
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US

    Narratives

    Description of Event or Problem · 1

    PHYSICIAN NOTICED THAT THE BIPOLAR PROBE WAS NOT COAGULATING BLOOD VESSELS AND THEN THE HANDPIECE HEATED UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WET-FIELD HEMOSTATIC ERASER BIPOLAR PROBE HQR MEDTRONIC OPHTHALMICS * *

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR