BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STORZ PREMIERE OPHTHALMIC MICROSURGICAL SYSTEM

    MDR report key: 41091 · Received September 16, 1996

    Report

    Report Number
    1920664-1996-00636
    Event Type
    Malfunction
    Date Received
    September 16, 1996
    Date of Event
    August 16, 1996
    Report Date
    August 16, 1996
    Manufacturer
    STORZ INSTRUMENT CO
    Product Code
    HQE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING A VITRECTOMY PROCEDURE, THERE WAS NO INTRA-OCULAR PRESSURE GOING TO THE EYE. THE PNEUMATIC SUPPLY LINE TO THE UNIT WAS RECONNECTED AND THEN THERE WAS A BLAST OF AIR INTO THE EYE. THE PROCEUDRE WAS THEN COMPLETED.

    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