BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    23 GAUGE HIGH SPEED VITRECTOMY CUTTER

    MDR report key: 3243233 · Received July 19, 2013

    Report

    Report Number
    1920664-2013-00188
    Event Type
    Malfunction
    Date Received
    July 19, 2013
    Date of Event
    June 24, 2013
    Report Date
    June 24, 2013
    Manufacturer
    BAUSCH & LOMB .
    Product Code
    HQC
    PMA / PMN Number
    K101325
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS DISPOSED RIGHT AFTER THE PROCEDURE BY THE HOSPITAL STAFF. THE STERILIZATION AND LOT HISTORY RECORDS WERE REVIEWED AND FOUND TO BE ACCEPTABLE.

    Description of Event or Problem · 1

    REPORT RECEIVED FROM SWITZERLAND STATED THAT DURING A PROCEDURE THE VITRECTOMY CUTTER WOULD NOT CUT AND NEEDED TO BE REPLACED. THE PROCEDURE WAS PROLONGED; HOWEVER, THERE WAS NO PT IMPACT OR INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    337951 23 GAUGE HIGH SPEED VITRECTOMY CUTTER HQC BAUSCH & LOMB . V0028

    Patients

    Seq Age Sex Outcome Treatment
    1 STELLARIS EQUIPMENT (BAUSCH + LOMB)