BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUMENIS PULSE 30H

    MDR report key: 13949506 · Received March 30, 2022

    Report

    Report Number
    3004135191-2022-00007
    Event Type
    Malfunction
    Date Received
    March 30, 2022
    Date of Event
    March 8, 2022
    Report Date
    March 30, 2022
    Manufacturer
    LUMENIS LTD.
    Product Code
    GEX
    UDI-DI
    07290109140698
    PMA / PMN Number
    K170121
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    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. THE SYSTEM WAS MANUFACTURED ON 03-OCT-2018 AND INSTALLED AT THE CUSTOMERS SITE ON (B)(6) 2019. A LUMENIS SERVICE ENGINEER VISITED THE SITE THIRTEEN (13) DAYS AFTER THE REPORTED EVENT AND EXAMINED THE DEVICE. THE ENGINEER WAS ABLE TO DUPLICATE THE ISSUE ON ARRIVAL, ERROR 02 - SHUTTER NOT CLOSED, CAME UP. REPLACED SHUTTER TO REPAIR ERROR 02. CHECKED BREAKER AND E-STOP. FOOT PEDAL CONNECTOR IS DAMAGED RESULTING IN NOT LOCKING IN POSITION. CHECKED OPTICS, DEBRIS SHIELD NEEDS REPLACEMENT. THE ENGINEER SUGGEST TO THE USER TO REPLACE THE FOOT PEDAL AND THE DEBRIS SHIELD. THE DEBRIS SHIELD IS A USER REPLACEABLE PART THAT PROTECTS THE LASER SYSTEM'S OPTICAL COMPONENTS FROM DAMAGE BY A FAILED DELIVERY SYSTEM. THE DEBRIS SHIELD IS LIKE A FUSE: YOU ONLY NEED TO REPLACE IT IF INSPECTION REVEALS THAT IT IS DAMAGED. WHEN A USER CHANGES A DEBRIS SHIELD, IT MAY ENABLE RESUMING THE OPERATION. A TWO-YEAR HISTORICAL REVIEW OF SIMILAR COMPLAINTS REVEALED THAT SHUTTER FAILURE DURING A PROCEDURE HAS NOT LED TO SERIOUS INJURY. A REVIEW OF SYSTEM RISK FILES (1003215 REV H) REVEALED RISK #2.2.2 " HW FAILURE" WHICH HAVE THE POTENTIAL TO LEAD TO INEFFECTIVE TREATMENT WHICH MAY REQUIRE RE-OPERATION -OR- PROLONGED PROCEDURE. 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. IN THIS CASE, THE PATIENT WAS AWAKENED FROM ANESTHESIA, THE PROCEDURE WAS CANCELLED, ALTHOUGH THERE WAS NO REPORT OF INJURY ASSOCIATED WITH THIS EVENT, LUMENIS BELIEVES THAT SUBJECTING A PATIENT TO ANOTHER ROUND OF ANESTHESIA CARRIES INHERENT RISKS, AND IN AN ABUNDANCE OF CAUTION, LUMENIS IS REPORTING THIS EVENT. ACCORDING TO THE GSO EXPERT BASED ON THE AGE OF THE SYSTEM, WEAR COULD HAVE LIKELY PLAYED A ROLE IN THE FAILURE. THEREFORE, NO ADDITIONAL CORRECTIVE OR PREVENTIVE ACTION IS DETERMINED NECESSARY. 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 · 0

    A USER FACILITY REPORTED THAT DURING A KIDNEY STONE PROCEDURE IN WHICH A LUMENIS PULSE 30H WAS BEING UTILIZED, THE SYSTEM DISPLAYED ERROR 02 - SHUTTER ERROR. UNABLE TO COMPLETE THE PROCEDURE, THE PATIENT WAS AWAKENED FROM GENERAL ANESTHESIA AND THE CASE NEEDED TO BE RESCHEDULED. NO REPORT OF PATIENT COMPLICATIONS WAS RECEIVED, AND NO REPORT WAS RECEIVED ALLEGING THE DEVICE MALFUNCTION CAUSED OR CONTRIBUTED TO ANY CHANGE IN THE PATIENT'S CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    761103 LUMENIS PULSE 30H HOLMIUM (HO:YAG) AND DUAL WAVELENGTH (HO:YAG/ND:YAG) GEX LUMENIS LTD. LUMENIS PULSE 30H 07290109140698

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown