BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STELLARIS 23GA POSTERIOR PACK

    MDR report key: 3040480 · Received April 3, 2013

    Report

    Report Number
    1920664-2013-00054
    Event Type
    Malfunction
    Date Received
    April 3, 2013
    Date of Event
    March 8, 2013
    Report Date
    March 8, 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 OPENED BL5623 POUCH FROM LOT U9434 WAS RETURNED. THE TIP PROTECTOR IS IN PLACE. THE NEEDLE IS NOT BENT. THE PORT WINDOW IS IN THE OPENED POSITION. THERE IS DRIED SOLUTION VISIBLE IN THE ASPIRATION LINE. THE BACK CAP IS ALIGNED CORRECTLY WITH THE VENT HOLE IN THE SIDE OF THE CUTTER BODY. A FUNCTIONAL TEST WAS PERFORMED USING A STELLARIS PC SYSTEM. THE INNER NEEDLE WILL NOT MOVE. THE CUTTER DOES ASPIRATE BUT WILL NOT CUT. THE STERILIZATION AND LOT HISTORY RECORDS HAVE BEEN REVIEWED AND FOUND TO BE ACCEPTABLE.

    Description of Event or Problem · 1

    THE USER FACILITY IN (B)(6) REPORTED THE CUTTER WORKED CORRECTLY DURING TRIAL CONNECTION. THEY STARTED WITH A LOW CUTTER SPEED; HOWEVER WHEN GEARED UP TO HIGHER SPEED THE CUTTER FUNCTION WAS NOT WORKING PROPERLY. DURING SURGERY THE CUTTER FAILED TO PROVIDE ADEQUATE CUTTING ACTION, BUT ASPIRATION CONTINUED. THERE WAS NO IMPACT TO THE PATIENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136902 STELLARIS 23GA POSTERIOR PACK HQC BAUSCH & LOMB, INC. BL5623 U9434

    Patients

    Seq Age Sex Outcome Treatment
    1