BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CATALYST PHACO MACHINE

    MDR report key: 36161 · Received August 21, 1996

    Report

    Report Number
    36161
    Event Type
    Injury
    Date Received
    August 21, 1996
    Date of Event
    August 14, 1996
    Report Date
    August 21, 1996
    Manufacturer
    CHIRON VISION CORP.
    Product Code
    HQC
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE MALFUNCTION OF PHACO HANDPIECE AND/OR MACHINE CAUSED TISSUE TO BURN BECAUSE OF INADEQUATE COOLING. IT IS TOO SOON TO TELL IF THERE WILL BE PERMANENT DAMAGE TO THE PT. TO DATE SHE IS HEALING WELL. THE CO REPRESENTATIVE WAS PRESENT DURING THE PROCEDURE TO SUPERVISE THE PHYSICIAN'S USE AS THE EQUIPMENT WAS ON TRIAL AND EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CATALYST PHACO MACHINE CATALYST ROTARY HQC CHIRON VISION CORP. HANDPIECE ND 750124 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention THE HAND PIECE ACTUALLY BURNED THE TISSUE. HOWEVER