BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KATENA

    MDR report key: 3964825 · Received July 10, 2014

    Report

    Report Number
    MW5037466
    Event Type
    Malfunction
    Date Received
    July 10, 2014
    Date of Event
    June 4, 2014
    Report Date
    June 4, 2014
    Manufacturer
    KATENA PRODUCTS INC
    Product Code
    HNZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    OUTPATIENT IN FOR CATARACT REPAIR. SURGEON USED CHOPPER DURING PROCEDURE AND WHEN THE INSTRUMENT WAS REMOVED, AN 1.5MM METAL TIP WAS MISSING FROM THE INSTRUMENT. INSTRUMENT DID NOT COME IN CONTACT WITH ANY HARD TISSUE OR SURFACES DURING THE PROCEDURE. THIS REQUIRED EXTENSIVE DIRECT VISUALIZATION OF THE AREA AND AN X-RAY TO RULE OUT THE PRESENCE OF A FOREIGN BODY WITHIN THE OCULAR CAVITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    404878 KATENA CHOPPER HNZ KATENA PRODUCTS INC K3-2398

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR