BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STELLARIS POWER SUPPLY II

    MDR report key: 17437987 · Received August 1, 2023

    Report

    Report Number
    0001920664-2023-70076
    Event Type
    Malfunction
    Date Received
    August 1, 2023
    Date of Event
    July 6, 2023
    Report Date
    July 7, 2023
    Manufacturer
    BAUSCH + LOMB
    Product Code
    HQC
    UDI-DI
    00757770524495
    PMA / PMN Number
    K063331
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A FIELD SERVICE TECHNICIAN AT THE USER FACILITY COULD NOT DUPLICATE THE CUSTOMERS REPORTED ISSUE, AND AS A PRECAUTION THE POWER SUPPLY AND THE POWER CORD WERE REPLACED. THE POWER SUPPLY WAS SENT TO THE DEPOT FOR EVALUATION. DEPOT EVALUATION OF THE POWER SUPPLY INCLUDED TESTING OVER THE COURSE OF 3.5 HOURS WHILE ACTIVATING PHACO AT DIFFERENT POWER SETTINGS AND PULSE MODES, THE TEST SYSTEM DID NOT POWER OFF DURING THIS TIME. MANUFACTURING AND STERILIZATION RECORDS WERE REVIEWED AND FOUND TO BE ACCEPTABLE. INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    CORRECTION: SECTION G4: FROM: K170052 TO: K063331 SECTION H6: TYPE FROM: 11 TO: 10.

    Additional Manufacturer Narrative · 0

    THE LOT HISTORY, TREND ANALYSIS, RISK ANALYSIS AND/OR DIRECTIONS FOR USE REVIEW WERE CONSIDERED ACCEPTABLE, WITH THE PRODUCT PERFORMING WITHIN ANTICIPATED RATES. PRODUCT EVALUATION DID NOT CONFIRM THE FAILURE AND WE ARE UNABLE TO DETERMINE THE ROOT CAUSE. NO CORRECTIVE ACTION REQUIRED.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THE SYSTEM POWERED OFF DURING SEGMENT REMOVAL, THEY WERE UNSURE IF IT WAS JUST THE DISPLAY OR WHOLE SYSTEM. POWER BUTTON WAS NOT ILLUMINATED DURING THE SHUTDOWN THEREFORE THE SYSTEM WAS SHUT DOWN. SURGERY WAS EXTENDED 15-20 MINUTES AND A FEW DROPS OF TOPICAL ANESTHESIA WAS NEEDED. THE PROCEDURE WAS FINISHED WITH A BACKUP SYSTEM, NO IMPACT TO PATIENT, AND WITHOUT FURTHER COMPLICATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SYSTEM POWERED OFF DURING SEGMENT REMOVAL, UNSURE IF JUST DISPLAY OF WHOLE SYSTEM. FINISHED PROCEDURE WITH BACKUP SYSTEM, NO IMPACT TO PATIENT. ((B)(6)). ADDITIONAL INFORMATION RECEIVED ON 10-JULY-2023: POWER BUTTON WAS NOT ILLUMINATED DURING THE SHUTDOWN, SURGERY WAS EXTENDED 15-20 MINUTES AND A FEW DROPS OF TOPICAL ANESTHESIA WAS NEEDED. PROCEDURE WAS FINISHED WITHOUT FURTHER COMPLICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1554599 STELLARIS POWER SUPPLY II UNIT, PHACOFRAGMENTATION HQC BAUSCH + LOMB BL2351 00757770524495

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown