BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUMENIS PULSE 120H

    MDR report key: 10560106 · Received September 21, 2020

    Report

    Report Number
    3004135191-2020-00066
    Event Type
    Malfunction
    Date Received
    September 21, 2020
    Date of Event
    September 4, 2020
    Report Date
    September 21, 2020
    Manufacturer
    LUMENIS LTD.
    Product Code
    GEX
    UDI-DI
    07290109140513
    PMA / PMN Number
    K170121
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LUMENIS INVESTIGATED THE REPORTED EVENT BY CONTACTING THE USER FACILITY DIRECTLY FOR ADDITIONAL INFORMATION. DESPITE REASONABLE ATTEMPTS, NO ADDITIONAL INFORMATION HAD BEEN PROVIDED. A REVIEW OF THE SUBJECT DEVICE DHR CONFIRMED THAT THE SUBJECT DEVICE WAS MANUFACTURED AND TESTED ACCORDING TO RELEVANT PROCEDURES, TESTED BEFORE RELEASE, AND SHIPPED ACCORDING TO MANUFACTURER'S SPECIFICATIONS. DEVICE WAS MANUFACTURED 4-DEC-2019 AND INSTALLED AT THE CUSTOMER'S SITE ON (B)(6) 2020. A REVIEW OF SUBJECT DEVICE PRODUCT RISK FILE (RD-1124690_AD) REVEALED RISK # 2.4.2; "SYSTEM FAILURE" WHICH HAS THE POTENTIAL TO LEAD TO PROLONGED PROCEDURE -OR- INEFFECTIVE TREATMENT WHICH MAY REQUIRE RE-OPERATION. THE RISK LIKELIHOOD HAS BEEN QUANTIFIED AND FOUND TO BE REMOTE, AND THE RISK HAS BEEN CHARACTERIZED AND DOCUMENTED AS ACCEPTABLE WITHIN A FULL RISK ASSESSMENT. A LUMENIS SERVICE ENGINEER VISITED THE SITE FOUR (4) DAYS AFTER THE REPORTED EVENT AND CONFIRMED ERRORS 223, 216. THE ENGINEER REPLACED THE SAFETY/IGBT MODULE AND THE SWITCHING MODULE. THE ENGINEER PERFORMED HV PMCU CALIBRATIONS, ADDED DISTILLED WATER, INSPECTED ALL OPTICS, VERIFIED OPTICAL ALIGNMENT, VERIFIED POWER CALIBRATION, UPGRADED SOFTWARE FROM 2.2.5.2 TO 2.3.0.4 IAC WITH TN-3200140 AND COMPLETED PREVENTIVE MAINTENANCE. AFTER TESTING THE SYSTEM, IT WAS RETURNED TO THE FACILITY HAVING MET MANUFACTURER'S SPECIFICATIONS. IN THIS CASE, IT WAS REPORTED THAT THE LASER WAS RUNNING IN CASE SAVER MODE AND NOT ALLOWING TO GET OFF STAND BY MODE. NO REPORT OF INJURY WAS RECEIVED, AND THE DEVICE MALFUNCTION DID NOT CAUSE OR CONTRIBUTE TO ANY CHANGE IN THE PATIENT'S CONDITION. ALTHOUGH THE DEVICE MALFUNCTION DID NOT CAUSE OR CONTRIBUTE TO ANY CHANGE IN THE PATIENT'S CONDITION, SINCE NO ADDITIONAL INFORMATION HAD BEEN PROVIDED. IN AN ABUNDANCE OF CAUTION, LUMENIS IS REPORTING THIS MALFUNCTION. LUMENIS TECHNICAL PROFESSIONAL INDICATED THAT THE MOST PROBABLE CAUSE OF THE SWM (SWITCHING MODULE) MALFUNCTION IS DUE TO ELECTRICAL BREAKDOWN BETWEEN THE LAMP WIRE AND THE OPTICAL BENCH. AS PART OF LUMENIS' COMMITMENT TO CONTINUOUS IMPROVEMENT, AN IMPROVED ISOLATION OF THE FLASH LAMP WIRES IS BEING RELEASED THROUGH ECO-0013696. LUMENIS IS CLOSING THIS COMPLAINT, BUT WILL CONTINUE TO MONITOR THIS FAILURE MODE; COMPLAINT TRENDING WILL CONTINUE TO MONITOR PER GLOBAL COMPLAINT HANDLING SOP (DOC NO. (B)(4) AND PER POST MARKETING SURVEILLANCE PROCEDURE (DOC NO. (B)(4).

    Description of Event or Problem · 1

    A USER FACILITY REPORTED THAT DURING A PROCEDURE IN WHICH A LUMENIS PULSE 120H WAS BEING UTILIZED THE LASER WAS RUNNING IN CASE SAVER MODE AND NOT ALLOWING TO GET OFF STAND BY MODE. NO REPORT OF INJURY WAS RECEIVED, AND THE DEVICE MALFUNCTION DID NOT CAUSE OR CONTRIBUTE TO ANY CHANGE IN THE PATIENT'S CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1026821 LUMENIS PULSE 120H HOLMIUM (HO:YAG) SURGICAL LASERS AND DELIVERY DEVICE GEX LUMENIS LTD. LUMENIS PULSE 120H 07290109140513

    Patients

    Seq Age Sex Outcome Treatment
    1