BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TSV 25 GA. HIGH SPEED POSTERIOR VITRECTOMY PACK

    MDR report key: 1052731 · Received May 23, 2008

    Report

    Report Number
    1920664-2008-00588
    Event Type
    Malfunction
    Date Received
    May 23, 2008
    Date of Event
    March 25, 2008
    Report Date
    April 30, 2008
    Manufacturer
    BAUSCH & LOMB
    Product Code
    KYG
    PMA / PMN Number
    K980488
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE VITRECTOMY CUTTER WOULD NOT CUT OR ASPIRATE PROPERLY DURING USE. THE TROCAR FELL OFF IN THE PATIENT'S EYE. THERE WAS NO INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TSV 25 GA. HIGH SPEED POSTERIOR VITRECTOMY PACK OPHTHALMIC MICROSURGICAL ACCESSORY PACK KYG BAUSCH & LOMB NA T8886

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention