BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STORZ PREMIERE OPHTHALMIC MICROSURGICAL SYSTEM

    MDR report key: 40879 · Received September 4, 1996

    Report

    Report Number
    1920664-1996-00608
    Event Type
    Malfunction
    Date Received
    September 4, 1996
    Date of Event
    July 7, 1996
    Report Date
    August 7, 1996
    Manufacturer
    STORZ INSTRUMENT CO
    Product Code
    HQE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THERE IS AN INTERMITTENT PROBLEM WITH THE FOOTPEDAL USED WITH THIS OPHTHALMIC MICROSURGICAL SYSTEM. IT WILL NOT FUNCTION WHEN OPERATED SLOWLY, BUT WILL FUNCTION WHEN STEPPED ON HARD. THE PROBLEM INITIALLY HAPPENED ABOUT ONE MONTH AGO AND HAS RECURRED INTERMITTENTLY SINCE THEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STORZ PREMIERE OPHTHALMIC MICROSURGICAL SYSTEM OPHTHALMIC MICROSURGICAL SYSTEM HQE STORZ INSTRUMENT CO NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO