BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KAUFMAN VITRECTOR III SYSTEM

    MDR report key: 12327 · Received March 28, 1994

    Report

    Report Number
    MW1001251
    Event Type
    Injury
    Date Received
    March 28, 1994
    Date of Event
    February 9, 1994
    Manufacturer
    XOMED-TREACE
    Product Code
    HQC
    Report Source
    Voluntary report
    Reporter Location
    ME, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING SURGERY FOR REMOVAL OF A CATARACT, ANOTHER CO'S AUTOMATIC ASPIRATOR/IRRIGATOR FAILED. WHILE THIS WAS BEING ASSESSED AND THE SVC TECH TELEPHONED, THE SURGEON REQUESTED MANUAL EQUIPMENT TO ASPIRATE AND IRRIGATE THE PARTICULATE MATTER (THE FRAGMENTED NUCLEUS). THE RUBBER SEAL DID NOT FUNCTION. AT THAT POINT, THIS DEVICE WAS REQUESTED. THE CONDOM PORTION OF THE DISPOSABLE PORTION HAD LOST ITS ELASTICITY. AS A RESULT, IT WAS ONLY WITH GREAT DIFFICULTY, EXTENSION OF THE TIME THE EYE WAS OPEN AND TRAUMA TO THE TISSUE THAT THE PROCEDURE WAS COMPLETED. THE PACKAGING ON THE EQUIPMENT HAS NO EXPIRATION DATE, THEREFORE HAD REMAINED AVAILABLE TO THE STAFF. THE MFR WAS NOTIFIED AND HAS VISITED HOSP TO INVESTIGATE THE EQUIPMENT. THE 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 MSDA WAS IMPLEMENTED. (SEE ALSO 1001250 AND 1001252.)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KAUFMAN VITRECTOR III SYSTEM HQC XOMED-TREACE 5098 30489

    Patients

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