BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TURBO SONICS ABS MICROTIP

    MDR report key: 1792004 · Received July 27, 2010

    Report

    Report Number
    1792004
    Event Type
    Malfunction
    Date Received
    July 27, 2010
    Date of Event
    July 21, 2010
    Report Date
    July 27, 2010
    Manufacturer
    ASCENT HEALTHCARE SOLUTIONS
    Product Code
    HQC
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    KY, US

    Narratives

    Description of Event or Problem · 1

    SURGEON PERFORMING PHACOEMULSIFICATION OF CATARACT USING OZIL PHACO HANDPIECE WITH A 30 DEGREES KELMAN PHACO TIP. TIP BROKE OFF IN EYE. PIECES RETRIEVED AND ANOTHER TIP ATTACHED TO HANDPIECE. SURGERY PROCEEDED. NO HARM TO PATIENT. CASE HAD MANY COMPLICATIONS BUT NONE DUE TO PHACO TIP MISHAP, ACCORDING TO SURGEON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TURBO SONICS ABS MICROTIP 30 DEGREE PHACO KELMAN TIP HQC ASCENT HEALTHCARE SOLUTIONS * 835017

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR