BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOFT TIP CANNULA, 25G

    MDR report key: 8178735 · Received December 19, 2018

    Report

    Report Number
    1211998-2018-00005
    Event Type
    Injury
    Date Received
    December 19, 2018
    Date of Event
    October 11, 2018
    Report Date
    December 18, 2018
    Manufacturer
    BEAVER-VISITEC, INTERNATIONAL, INC
    Product Code
    HMX
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    1211998-11/26/2018-004-R
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT HAS BEEN SUBMITTED ON WED NOV 14 23:46:22 EST 2018 FORM 3500A THROUGH ESG PRODUCTION SYSTEM. THIS REPORT IS BEING RESUBMITTED WITH UPDATED INFORMATION.

    Description of Event or Problem · 1

    A SOFT TIP CANNULA DESIGNED FOR VITREORETINAL PROCEDURES HAS A SILICON TIP. A FRAGMENT OF THE SILICON TIP "FELL OFF" INTRAOCULAR DURING A VITREORETINAL PROCEDURE. THE SURGEON WAS ABLE TO RETRIEVE THE FRAGMENT OF SILICON USING A VITRECTOMY DEVICE. THE SILICON TIP WAS REMOVED WITHOUT INJURY TO THE PATIENT'S EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1020333 SOFT TIP CANNULA, 25G MANUAL OPHTHALMIC SURGICAL INSTRUMENT. CANNULA, OPHTHALMIC HMX BEAVER-VISITEC, INTERNATIONAL, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R