BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STELLARIS 25GA POSTERIOR PACK W AFI & WF

    MDR report key: 3070336 · Received April 17, 2013

    Report

    Report Number
    1920664-2013-00084
    Event Type
    Malfunction
    Date Received
    April 17, 2013
    Date of Event
    March 18, 2013
    Report Date
    March 18, 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

    THE DEVICE HAS NOT BEEN RECEIVED FOR EVALUATION AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE FILLED SHOULD ANY ADDITIONAL INFORMATION BECOME AVAILABLE FOR INVESTIGATION A LOT NUMBER WAS NOT PROVIDED; THEREFORE THE STERILIZATION AND LOT HISTORY RECORDS COULD NOT BE REVIEWED. REPORT 1 OF 2. SEE 1920664-2013-00085.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED A CUTTER FAILURE. THEY WERE USING A CUTTER THAT STOPPED CUTTING. THEY OPENED ANOTHER CUTTER TO FINISH THE CASE. IT ALSO STOPPED CUTTING, BUT STARTED AGAIN AND THE SURGERY WAS COMPLETED. NO PATIENT IMPACT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    164857 STELLARIS 25GA POSTERIOR PACK W AFI & WF HQC BAUSCH & LOMB, INC. BL5425W UNK

    Patients

    Seq Age Sex Outcome Treatment
    1