BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SITE MICROSURGICAL SYSTEMS, INC.

    MDR report key: 17201 · Received August 31, 1994

    Report

    Report Number
    17201
    Event Type
    Injury
    Date Received
    August 31, 1994
    Date of Event
    August 22, 1994
    Report Date
    August 31, 1994
    Manufacturer
    SITE MICROSURGICAL SYSTEMS, INC.
    Product Code
    HQC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT WAS THE SECOND CASE FOR PHACO CATARACT EXTRACTION USING THE IRRIGATION AND ASPIRATION MODULE. THE FIRST CASE WAS COMPLETED WITHOUT INCIDENT. DURING THE PHACOEMULSIFICATION PHASE, AFTER THREE PARTS OF THE FRACTURE WERE MADE, AND WHILE BEGINNING ON THE FOURTH ARM OF THE FRACTURE, SOME INSTANTANEOUS CORNEAL WHITENING WAS NOTED. PHACOEMULSIFICATION WAS IMMEDIATELY STOPPED AND THE PHACO TIP REMOVED FROM THE EYE. THE LINES WERE CHECKED AND IT APPEARED THAT IRRIGATION WAS NORMAL THROUGH THE INSTRUMENT. HAVING NO OTHER RECOURSE AT THAT POINT, SINCE THE PHACOEMULSIFICATION HAD ALREADY BEGAN AND THERE WAS A SMALL PUPIL, THE TIP WAS PLACED BACK IN THE EYE AND THE REMAINDER OF THE NUCLEUS WAS PHACOEMULSIFIED WITHOUT COMPLICATION. A SCLERAL PATCH WAS PERFORMED ON THE PT. THE PHYSICIAN SUSPECTED THAT A REDUCED IRRIGATION FLOW THROUGH THE HANDPIECE WAS THE CAUSE OF THE OVERHEATING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SITE MICROSURGICAL SYSTEMS, INC. PHACO MODULE HQC SITE MICROSURGICAL SYSTEMS, INC. 501-3760

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Required Intervention