BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STELLARIS 25GA COMB VITRECTOMY PK W WF

    MDR report key: 3193147 · Received June 25, 2013

    Report

    Report Number
    1920664-2013-00146
    Event Type
    Malfunction
    Date Received
    June 25, 2013
    Date of Event
    May 28, 2013
    Report Date
    May 28, 2013
    Manufacturer
    BAUSCH & LOMB, INC.
    Product Code
    HQC
    PMA / PMN Number
    K101325
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL COMPLETED. ONE 25GA CUTTER WAS RETURNED IN A PLASTIC ZIP LOCK BAG. THE ORIGINAL PACKAGING WAS NOT RETURNED. THE PART NUMBER AND LOT NUMBER CANNOT BE VERIFIED. THE TIP PROTECTOR WAS IN PLACE. THE NEEDLE WAS SLIGHTLY BENT APPROX 5 DEGREES OR LESS. THE PORT WINDOW WAS IN THE OPENED POSITION. THERE WAS DEBRIS VISIBLE INSIDE THE PORT AND AROUND THE PORT WINDOW ON THE OUTER NEEDLE SHAFT. THERE WAS DRIED SOLUTION IN THE TUBING. THE EXTENSION HANDLE WAS AROUND THE TUBING BUT NO ATTACHED TO THE CUTTER BACK CAP. THE BACK CAP WAS ALIGNED CORRECTLY WITH THE VENT HOLE IN THE SIDE OF THE CUTTER BODY. A FUNCTIONAL TEST WAS PERFORMED USING A STELLARIS PC SYSTEM. THE CUTTER DID RELEASE ONE AIR BUBBLE FROM THE PORT AT THE INITIAL START UP. THE CUTTER HAD GOOD CLEAN CUTS AT VARIOUS CUT RATES. THE CUTTER HAD GOOD ASPIRATION AND FUNCTIONED AS REQUIRED. THE STERILIZATION AND LOT HISTORY RECORDS HAVE BEEN REVIEWED AND FOUND TO BE ACCEPTABLE.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED VITRECTOMY CUTTER WAS NOT PERFORMING UPON ACTIVATION. THERE WERE BUBBLES COMING FROM THE TOP OF THE CUTTER AND IT WAS MAKING A NOISE. THE CUTTER SUBSEQUENTLY BEGAN TO CUT PROPERLY AND THE PROCEDURE WAS COMPLETELY WITH NO FURTHER INCIDENTS. THERE WAS PT CONTACT BUT NO INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    288178 STELLARIS 25GA COMB VITRECTOMY PK W WF HQC BAUSCH & LOMB, INC. BL5325W V0289

    Patients

    Seq Age Sex Outcome Treatment
    1