BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SITE TXR MICROSURGICAL SYSTEM

    MDR report key: 2874 · Received July 9, 1992

    Report

    Report Number
    2874
    Event Type
    Injury
    Date Received
    July 9, 1992
    Date of Event
    February 26, 1992
    Report Date
    March 2, 1992
    Manufacturer
    SITE MICROSURGICAL SYSTEM, INC.
    Product Code
    GZX
    Adverse Event
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    MICROSCOPE IS USED DURING THIS PROCEDURE. DURING THE COURSE OF PLACING AN ANTERIOR CHAMBER EYE LENS THE PATIENT'S OWN CATARACT LENS CUT THROUGH AND WAS LOST IN BACK OF THE EYE. THE PATIENT WAS TRANSFERRED TO A HOSPITAL TO HAVE IT REMOVEDDEVICE NOT LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: SATISFACTORY CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.DEVICE SERVICED IN ACCORDANCE WITH SERVICE SCHEDULE. DATE LAST SERVICED: 01-NOV-91. SERVICE PROVIDED BY: MANUFACTURER. SERVICE RECORDS AVAILABLE.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.DEVICE WAS NOT EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: NO DATA. RESULTS OF EVALUATION: NO DATA. CONCLUSION: NO DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: MAYBE. CORRECTIVE ACTIONS: DEVICE TEMPORARILY REMOVED FROM SERVICE. THE DEVICE WAS NOT DESTROYED/DISPOSED OF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SITE TXR MICROSURGICAL SYSTEM GZX SITE MICROSURGICAL SYSTEM, INC. 5011045

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Required Intervention