BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STELLARIS 23GA POSTERIOR PACK

    MDR report key: 3063618 · Received April 12, 2013

    Report

    Report Number
    1920664-2013-00068
    Event Type
    Malfunction
    Date Received
    April 12, 2013
    Date of Event
    March 6, 2013
    Report Date
    March 15, 2013
    Manufacturer
    BAUSCH & LOMB, INC.
    Product Code
    HQC
    PMA / PMN Number
    K101325
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION COMPLETED. ONE 23GA CUTTER WAS RETURNED IN A PLASTIC BAG WITHOUT THE ORIGINAL PACKAGING. THE PART NUMBER AND LOT NUMBER CANNOT BE VERIFIED OR DETERMINED. THE TIP PROTECTOR WAS IN PLACE, AS IT SHOULD BE. THE NEEDLE WAS BENT 5 DEGREE OR LESS. THE PORT WINDOW WAS IN THE OPENED POSITION. THERE WAS DRIED SOLUTION VISIBLE IN THE TUBING. 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. AT 5000 C.P. M., THE INNER NEEDLE WAS FOUND TO BE STUCK AND WOULD NOT MOVE. THE CUTTER RATE WAS REDUCED TO 2000 C.P.M. AT WHICH POINT THE INNER NEEDLE BROKE LOOSE AND BEGAN TO MOVE. THE CUTTER HAD GOOD CLEAN CUTS AND ASPIRATION AT VARIOUS RANGES AND CUT RATES. IT CANNOT BE DETERMINED IF THE INNER NEEDLE WAS STUCK AND WOULDN'T MOVE DUE TO THE DRIED SOLUTION OR FOR OTHER UNKNOWN REASONS. IT SHOULD BE NOTED THAT A BENT NEEDLE CONDITION COULD CONTRIBUTE TO POOR CUTTING PERFORMANCE. THE STERILIZATION AND LOT HISTORY RECORDS HAVE BEEN REVIEWED AND FOUND TO BE ACCEPTABLE.

    Additional Manufacturer Narrative · 1

    EVALUATION COMPLETED. ONE 23GA CUTTER WAS RETURNED IN A PLASTIC BAG WITHOUT THE ORIGINAL PACKAGING. THE PART NUMBER AND LOT NUMBER CANNOT BE VERIFIED OR DETERMINED. THE TIP PROTECTOR WAS IN PLACE, AS IT SHOULD BE. THE NEEDLE WAS BENT 5 DEGREE OR LESS. THE PORT WINDOW WAS IN THE OPENED POSITION. THERE WAS DRIED SOLUTION VISIBLE IN THE TUBING. 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. AT 5000 C.P. M., THE INNER NEEDLE WAS FOUND TO BE STUCK AND WOULD NOT MOVE. THE CUTTER RATE WAS REDUCED TO 2000 C.P.M. AT WHICH POINT THE INNER NEEDLE BROKE LOOSE AND BEGAN TO MOVE. THE CUTTER HAD GOOD CLEAN CUTS AND ASPIRATION AT VARIOUS RANGES AND CUT RATES. IT CANNOT BE DETERMINED IF THE INNER NEEDLE WAS STUCK AND WOULDN'T MOVE DUE TO THE DRIED SOLUTION OR FOR OTHER UNKNOWN REASONS. IT SHOULD BE NOTED THAT A BENT NEEDLE CONDITION COULD CONTRIBUTE TO POOR CUTTING PERFORMANCE. THE STERILIZATION AND LOT HISTORY RECORDS HAVE BEEN REVIEWED AND FOUND TO BE ACCEPTABLE.

    Description of Event or Problem · 1

    THE USER FACILITY IN KOREA REPORTED A PATIENT WAS UNDERGOING SURGERY THE CUTTER DID NOT FUNCTION PROPERLY. THEY STARTED WITH A LOW CUTTER SPEED; HOWEVER, WHEN GEARED UP TO A HIGHER SPEED THE CUTTER FUNCTION WAS NOT WORKING PROPERLY. DURING SURGERY THE CUTTER FAILED TO PROVIDE ADEQUATE CUTTING ACTION, BUT ASPIRATION CONTINUED. THE CUTTER WORKED CORRECTLY DURING TRIAL CONNECTION. THERE WAS NO IMPACT TO THE PATIENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    158054 STELLARIS 23GA POSTERIOR PACK HQC BAUSCH & LOMB, INC. BL5623 U9434

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR