BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUMENIS PULSE120H

    MDR report key: 9254413 · Received October 30, 2019

    Report

    Report Number
    3004135191-2019-00117
    Event Type
    Malfunction
    Date Received
    October 30, 2019
    Date of Event
    October 4, 2019
    Report Date
    October 30, 2019
    Manufacturer
    LUMENIS LTD.
    Product Code
    GEX
    UDI-DI
    07290109140513
    PMA / PMN Number
    K170121
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A LUMENIS SERVICE ENGINEER VISITED THE SITE FOUR (4) DAYS AFTER THE REPORTED EVENT AND EXAMINED THE SYSTEM HAVING CONFIRMED THAT THE 45° MIRROR WAS DAMAGED. THE ENGINEER ORDERED REPLACEMENT PARTS AND WILL RETURN TO REPLACE THE MIRROR. 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 11-DEC-2018 AND INSTALLED AT THE CUSTOMERS SITE ON (B)(6) 2019. A REVIEW OF HISTORICAL PRODUCT COMPLAINTS SHOWS THAT THE SAME MALFUNCTION OF ERROR 87 OR DAMAGED 45° MIRROR' HAS NOT LED TO SERIOUS INJURY IN THE PAST. A REVIEW OF SYSTEM RISK FILES ((B)(4)) REVEALED RISK #2.3.1; OPTICAL MISALIGNMENT FAILURE WHICH HAS THE POTENTIAL TO LEAD TO PROLONGED PROCEDURE -OR- INEFFECTIVE TREATMENT WHICH MAY REQUIRE RE-OPERATION. THE RISK HAS BEEN QUANTIFIED AND FOUND TO BE REMOTE, AND THE RISK HAS BEEN CHARACTERIZED AND DOCUMENTED AS ACCEPTABLE WITHIN FULL RISK ASSESSMENT. IN THIS CASE, THEY SWITCHED FROM THE LASER TO A MANUAL LITHOCLAST PROCEDURE IN ORDER TO COMPLETE THE CASE WITH NO COMPLICATIONS TO THE PATIENT. ALTHOUGH THE DEVICE MALFUNCTION DID NOT CAUSE OR CONTRIBUTE TO ANY CHANGE IN THE PATIENT'S CONDITION, IT IS UNCERTAIN IF THE USER FACILITY HAD TO USE THE ALTERNATE METHOD AS INTERVENTION TO PREVENT PERMANENT DAMAGE. IN AN ABUNDANCE OF CAUTION LUMENIS IS REPORTING THIS MALFUNCTION. LUMENIS HAS INITIATED CAPA #(B)(4) TO FURTHER INVESTIGATE OPTICS ISSUES WITH THE HOLMIUM PRODUCT FAMILY LASERS. INVESTIGATION IS STILL ONGOING, AND IF THERE WILL BE A SIGNIFICANT CHANGE, THEN LUMENIS WILL FILE A FOLLOW-UP MDR.

    Description of Event or Problem · 1

    A USER FACILITY REPORTED THAT DURING A BLADDER STONE BREAKAGE PROCEDURE IN WHICH A LUMENIS PULSE 120H LASER WAS BEING UTILIZED, THE SYSTEM DISPLAYED ERROR CODES 253, 269, 251, AND 87 AND IMMEDIATELY DISABLED THE LASER. THE SCREEN NOTIFICATION READ, "AN ERROR HAS OCCURRED AND THE SYSTEM CANNOT LASE. PLEASE CALL SERVICE". THE USER FACILITY TRIED TO TROUBLESHOOTING BUT AFTER 20-30 MINUTES, THEY SWITCHED FROM THE LASER TO A MANUAL LITHOCLAST PROCEDURE, WHICH EXTENDED THE SURGERY TIME BY ANOTHER 30 MINUTES. 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
    1048910 LUMENIS PULSE120H HOLMIUM (HO:YAG) SURGICAL LASERS AND DELIVERY DEVICE GEX LUMENIS LTD. LUMENIS PULSE120H 07290109140513

    Patients

    Seq Age Sex Outcome Treatment
    1