BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SITE MICROSURGICAL UNIT

    MDR report key: 35290 · Received July 5, 1996

    Report

    Report Number
    35290
    Event Type
    Malfunction
    Date Received
    July 5, 1996
    Date of Event
    June 17, 1996
    Report Date
    June 30, 1996
    Manufacturer
    SITE MICROSURGICAL SYSTEMS, INC.
    Product Code
    HQC
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PHYSICIAN IS CONCERNED THAT A METAL FRAGMENT MIGHT HAVE COME OFF THE PHACO TIP SINCE A .2MM PARTICLE WAS FOUND IN A SECOND PT'S EYE DURING CATARACT SURGERY (SEE CO'S MCI REPORT SENT WITH THIS REPORT). AFTER REPORTS OF TESTING THERE SHOULD BE NO PROBLEM FOR THE PT, PER PHYSICIAN AND FOLLOW-UP WILL CONTINUE. NO FRAGMENTS OBSERVED WITH THIS PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SITE MICROSURGICAL UNIT MICROSURGICAL UNIT HQC SITE MICROSURGICAL SYSTEMS, INC. 501-1045 301612, 301613

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Other