BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STORZ KELLY DECEMET MEMBRANE PUNCH

    MDR report key: 64487 · Received January 17, 1997

    Report

    Report Number
    1932180-1997-00009
    Event Type
    Malfunction
    Date Received
    January 17, 1997
    Date of Event
    November 15, 1996
    Report Date
    December 18, 1996
    Manufacturer
    STORZ INSTRUMENT COMPANY
    Product Code
    HNJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    IMPROPER CLEANING HAS BEEN DETERMINED TO BE THE CAUSE OF THIS EVENT.

    Description of Event or Problem · 1

    THIS INSTRMENT WAS RECEIVED IN FEBRUARY 1996. THEY HAVE BECOME RUSTY AND PARTICLES OF RUST HAVE FALLEN INTO THE EYE DURING PROCEDURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STORZ KELLY DECEMET MEMBRANE PUNCH MEMBRANE PUNCH HNJ STORZ INSTRUMENT COMPANY NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO