BEUDAMED
    FDA Adverse Event Other Summary report: N

    FINE-NAGAHARA PHACO CHOPPER

    MDR report key: 260498 · Received January 26, 2000

    Report

    Report Number
    1051791-2000-00001
    Event Type
    Other
    Date Received
    January 26, 2000
    Date of Event
    January 19, 2000
    Report Date
    January 20, 2000
    Manufacturer
    RHEIN MEDICAL, INC.
    Product Code
    HNR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING EYE SURGERY THE TIP OF AN INSTRUMENT BROKE OFF IN THE PT'S EYE. THE TIP MAY HAVE COME IN CONTACT WITH THE PHACO TIP, WHICH IS AN ULTRASONIC VIBRATOR. THE HOSP STAFF IS NOT SURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FINE-NAGAHARA PHACO CHOPPER OPHTHALMIC FORCEPS HNR RHEIN MEDICAL, INC. 08-14503L NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention