BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STORZ PHACOEMULSIFICATION HANDPIECE

    MDR report key: 41957 · Received September 19, 1996

    Report

    Report Number
    1920664-1996-00643
    Event Type
    Malfunction
    Date Received
    September 19, 1996
    Date of Event
    August 20, 1996
    Report Date
    August 20, 1996
    Manufacturer
    STORZ INSTRUMENT CO.
    Product Code
    HQC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING A CATARACT EXTRACTION PROCEDURE, THIS PHACOEMULSIFICATION HANDPIECE COULD NOT BE CALIBRATED. ANOTHER HANDPIECE WAS USED TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STORZ PHACOEMULSIFICATION HANDPIECE PHACOEMULSIFICATION HANDPIECE HQC STORZ INSTRUMENT CO. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO