BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AUTOMATIC ASPIRATOR/IRRIGATOR

    MDR report key: 12328 · Received March 28, 1994

    Report

    Report Number
    MW1001252
    Event Type
    Injury
    Date Received
    March 28, 1994
    Date of Event
    February 9, 1994
    Manufacturer
    SITE MICROSURGICAL SYSTEMS, INC.
    Product Code
    HQC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    ME, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DEVICE MODULE STOPPED FUNCTIONING. ONCE THAT IS INOPERABLE, THE WHOLE MACHINE CEASES TO FUNCTION; WILL NOT ASPIRATE. SVC TECH REACHED BY PHONE. IN 20 MINS TECH DETERMINED THAT SUCTION PINCH BAR WAS IMPAIRED. THE MACHINE WAS RETURNED TO MFR AND IMMEDIATELY REPLACED. EXTENT OF THE PERMANENT DAMAGE TO THE PT'S EYE HAS NOT YET BEEN DETERMINED BY THE SURGEON. THIS IS THE FIRST INCIDENT OF THIS SEVERITY TO HAVE TAKEN PLACE IN HOSP SINCE THE SMDA WAS IMPLEMENTED. (ALSO SEE 1001250 AND 1001251.)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOMATIC ASPIRATOR/IRRIGATOR HQC SITE MICROSURGICAL SYSTEMS, INC. 501-1045

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Not Applicable| O