BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RHEIN MEDICAL I/A HANDPIECE

    MDR report key: 404891 · Received July 12, 2002

    Report

    Report Number
    404891
    Event Type
    Malfunction
    Date Received
    July 12, 2002
    Date of Event
    April 17, 2002
    Report Date
    July 10, 2002
    Manufacturer
    RHEIN MEDICAL INC
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CO, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING THE COURSE OF A ROUTINE CATARACT EXTRACTION, WHAT APPEARED TO BE MICROSCOPIC METAL FRAGMENTS ENTERED THE ANTERIOR CHAMBER OF THE EYE. AN IRRIGATION-ASPIRATION HANDPIECE WAS IN USE. THERE APPEARED TO BE A CRACK IN THE OUTER CASING OF THE HANDPIECE. ANOTHER STERILE HANDPIECE WAS OBTAINED AND THE PARTICLES WERE EASILY ASPIRATED. NO PT INJURY OR ADVERSE REACTION OCCURRED. THE SUSPECT HANDPIECE WAS SENT TO RHEIN MEDICAL (THE MFR) FOR INSPECTION AND EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RHEIN MEDICAL I/A HANDPIECE IRRIGATION AND ASPIRATION HANDPIECE GEI RHEIN MEDICAL INC 99IH90100 *

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other