BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TXR

    MDR report key: 641 · Received May 29, 1992

    Report

    Report Number
    641
    Event Type
    Injury
    Date Received
    May 29, 1992
    Date of Event
    May 6, 1992
    Report Date
    May 13, 1992
    Manufacturer
    SITE-MICROSURGICAL SYSTEMS, INC.
    Product Code
    HQC
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    WHILE DOING A ROUTINE CATERACT EXTRACTION, USING THE PHACO, THE PATIENT SUSTAINED A CORNEAL BURN TO THE EYE. THE SURGEON WAS USING THE PHACO ON 40 WITH 4 ON SUCTION. PHACO POWER WAS INCREASED TO 60, THEN RETURNED TO 40 WITHOUT INCIDENT. AGAIN, THE POWER WAS INCREASED TO 60 AND THE BURN OCCURRED. THE CASE WAS FINISHED IN A ROUTINE MANNER. TOTAL PHACO TIME WAS 3.59.DEVICE NOT LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: UNKNOWN. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.DEVICE SERVICED IN ACCORDANCE WITH SERVICE SCHEDULE. DATE LAST SERVICED: 01-MAR-92. SERVICE PROVIDED BY: USER FACILITY BIOMEDICAL/BIOENGINEERING DEPARTMENT. SERVICE RECORDS AVAILABLE.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, PERFORMANCE TESTS PERFORMED. RESULTS OF EVALUATION: TELEMETRY FAILURE, NONE OR UNKNOWN, NONE OR UNKNOWN, NONE OR UNKNOWN. CONCLUSION: NONE OR UNKNOWN. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: DEVICE RETURNED TO MANUFACTURER/DEALER/DISTRIBUTOR. THE DEVICE WAS NOT DESTROYED/DISPOSED OF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TXR PHACOFRAGMENTATION UNIT HQC SITE-MICROSURGICAL SYSTEMS, INC. 501-1045/1850201 *

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention