BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STELLARIS OPTIMIZED STABILITY VACUUM PACK

    MDR report key: 2101962 · Received May 18, 2011

    Report

    Report Number
    1920664-2011-00034
    Event Type
    Malfunction
    Date Received
    May 18, 2011
    Date of Event
    April 19, 2011
    Report Date
    April 19, 2011
    Manufacturer
    BAUSCH & LOMB
    Product Code
    HQC
    PMA / PMN Number
    P063331
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    STERILIZATION AND LOT HISTORY RECORDS WERE REVIEWED AND NO EXCEPTIONS WERE FOUND.

    Description of Event or Problem · 1

    REPORT RECEIVED FROM (B)(6) STATES: "AFTER ONE TO FOUR SECONDS CUTTER FAILED TO CUT EFFICIENTLY. SURGEON STATED ASPIRATION OF VITREOUS WAS OBVIOUS AS TRACTION OCCURRED. COULD NOT SPECIFY VISUALLY IF CUTTER WAS ACTUATING OR NOT. CUTTER SOUND WAS PRESENT. CUTTER WAS MAKING A DISTINCT RATTLING NOISE AND VIBRATING EXCESSIVELY AT 2500CPM. CUTTER EXTENSION HAND GRIP WAS USED FOR THIS CUTTER. SURGEON AT THIS TIME CEASED PROCEDURE AND WAS NOT SATISFIED WITH OUTCOME. PROCEDURE INCOMPLETE AND LESS THAN SATISFACTORY. NO PATIENT INJURY AT THE TIME BUT LESS THAN FAVORABLE OUTCOME FOR PATIENT AS SURGEON COULD NOT COMPLETE THE PROCEDURE EFFECTIVELY. OUTCOME YET TO BE DETERMINED." ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STELLARIS OPTIMIZED STABILITY VACUUM PACK HQC BAUSCH & LOMB U5035

    Patients

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