BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NIDEK

    MDR report key: 287351 · Received July 23, 2000

    Report

    Report Number
    MW1019376
    Event Type
    Injury
    Date Received
    July 23, 2000
    Date of Event
    July 8, 1999
    Report Date
    July 23, 2000
    Manufacturer
    NIDEK
    Product Code
    HQE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    DURING VITREOUS SURGERY THE FGX PUMP SUDDENLY STOPPED AIR PUMPING LEADING TO SUDDEN DECOMPRESSION WITH SUPRACHOROIDAL HEMORRHAGE. THE AIR PUMP NEEDED REPLACEMENT THEN. HOWEVER, THE MACHINE HAS MALFUNCTIONED AGAIN. CO IS NOT PROVIDING PROPER POST SALES SVC AND IS NOT TAKING RESPONSIBILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NIDEK VT 5000 SURGICAL VITRECTOMY SYSTEM HQE NIDEK VT 5000 *

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention| S