BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GREENLIGHT HPS LASER SYSTEM

    MDR report key: 8782649 · Received July 11, 2019

    Report

    Report Number
    2937094-2019-60849
    Event Type
    Injury
    Date Received
    July 11, 2019
    Date of Event
    June 12, 2019
    Report Date
    November 13, 2019
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    GEX
    PMA / PMN Number
    K062719
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE LASER CONSOLE WAS INVESTIGATED AND REPAIRED IN THE FIELD. THE REPORTED ERROR CODES WERE CONFIRMED. THE RESONATOR WAS REPLACED AND THE ISSUE WAS RESOLVED. THE SYSTEM WAS TESTED AND VERIFIED TO FUNCTION ACCORDING TO MANUFACTURER'S SPECIFICATIONS. AN INVESTIGATION CONCLUSION CODE OF CAUSE TRACED TO COMPONENT FAILURE WAS ASSIGNED TO THIS INVESTIGATION. THE ISSUE WAS MOST LIKELY DUE TO AN ELECTRICAL FAILURE WITHIN THE RESONATOR. ISSUES WITH THE RESONATOR CAN TRIGGER ADDITIONAL ERROR CODES.

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORD (DHR) CONFIRMED THAT THE DEVICES MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE LASER CONSOLE WAS INVESTIGATED AND EVALUATION SUSPECTED THE RESONATOR WAS THE ISSUE. IN ADDITION, THE SERVICE REPAIR FOUND THAT THE DIODE WAS DAMAGE DUE TO AN OVER VOLTAGE CONDITION, THE LBO (LENS) ON RAM SIDE WAS BURNT AND WATER FITTINGS FOR THE DIODE WERE LEAKING. THE RESONATOR ALONG WITH THE LBO (LENS) ON RAM SIDE, AND DESICCANT PACKS WERE REPLACED. THE SYSTEM WAS TESTED AND VERIFIED TO FUNCTION ACCORDING TO MANUFACTURER SPECIFICATIONS, THE REPORTED ISSUE WAS RESOLVED. BASED ON THE OBSERVED ONSITE CONSOLE EVALUATION AND REPAIRS, AND EVALUATION CONCLUSION CODE OF CAUSE TRACED TO COMPONENT FAILURE WAS ASSIGNED TO THIS INVESTIGATION. THE SYSTEM WAS TESTED AND VERIFIED TO FUNCTION ACCORDING TO MANUFACTURER'S SPECIFICATIONS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A PROCEDURE ERRORS 211, 202 AND 111 OCCURRED. THE SYSTEM WAS RESTARTED BUT THE ERRORS COULD NOT BE CLEARED. A SECOND FIBER WAS CONNECTED WITH THE SAME RESULTS. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. THERE WAS NO PATIENT HARM.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A PROCEDURE ERRORS 211, 202 AND 111 OCCURRED. THE SYSTEM WAS RESTARTED BUT THE ERRORS COULD NOT BE CLEARED. A SECOND FIBER WAS CONNECTED WITH THE SAME RESULTS. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. THERE WAS NO PATIENT HARM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE ERRORS 211, 202 AND 111 OCCURRED. THE SYSTEM WAS RESTARTED BUT THE ERRORS COULD NOT BE CLEARED. A SECOND FIBER WAS CONNECTED WITH THE SAME RESULTS. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. THERE WAS NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    575792 GREENLIGHT HPS LASER SYSTEM POWERED LASER SURGICAL INSTRUMENT GEX BOSTON SCIENTIFIC CORPORATION 0010-0077 HPS3210

    Patients

    Seq Age Sex Outcome Treatment
    1 Other