BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUMENIS PULSE100H

    MDR report key: 8149968 · Received December 11, 2018

    Report

    Report Number
    3004135191-2018-00171
    Event Type
    Malfunction
    Date Received
    December 11, 2018
    Date of Event
    November 19, 2018
    Report Date
    December 10, 2018
    Manufacturer
    LUMENIS LTD.
    Product Code
    GEX
    PMA / PMN Number
    K170121
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    LUMENIS IS NOT THE MANUFACTURER OF THE FIBER WHOSE FIBER CONNECTOR WAS REPORTED TO HAVE BURNED A USER IN THIS EVENT AND RESULTING IN INJURY. THE MANUFACTURER OF THE FIBER HAS BEEN MADE AWARE OF THE FIBER ISSUE. INVESTIGATION OF SIMILAR EVENTS OF NON-LUMENIS FIBER CONNECTORS OVERHEATING HAS BEEN DOCUMENTED IN (B)(4) UNDER COMPLAINT (B)(4). "ALL LUMENIS FIBERS ARE BONDED INTO THE METAL FERRULE. BECAUSE THERE IS A LAYER OF GLUE BETWEEN THE FIBER AND THE METAL FERRULE, ANY FAILURE OF THE FIBER IN THE CONNECTOR OR MISALIGNMENT OF THE LASER BEAM WILL FIRST OF ALL CAUSE THE GLUE TO BE BURNED. THIS IN TURN WILL CAUSE THE BLAST SHIELD TO FAIL WITH VERY OBVIOUS NOISE, SMELL AND PERFORMANCE LOSS. FURTHERMORE, THE GLUE BURNING OCCURS VERY FAST, IN A COUPLE OF SECONDS. THE TIME CONSTANT OF THE CONNECTOR THERMAL RESPONSE IS ABOUT 100 SECONDS. THEREFORE, THE CONNECTOR HEATING BEFORE THE GLUE BURNING IS NEGLIGIBLE, AND IT IS HIGHLY UNLIKELY TO BE BURNED BY IT. " A TWO YEAR HISTORICAL REVIEW OF SIMILAR COMPLAINTS REVEALED NO EVENTS INVOLVING LUMENIS FIBERS AND USERS BEING BURNED ON OVERHEATED LASER FIBER CONNECTORS. TO DATE LUMENIS IS UNAWARE OF SUCH EVENTS EVER HAVING BEEN REPORTED. A LUMENIS SERVICE ENGINEER VISITED THE SITE ONE WEEK AFTER THE REPORTED EVENT. THE ENGINEER INSPECTED THE LASER'S OPTICS AND ALIGNMENT - ALIGNMENT WAS CENTER ON ALL FOUR CHANNELS. THE ENGINEER CHECKED ENERGY AT DIFFERENT SETTINGS - LASER PUTTING OUT CORRECT ENERGY PER SETTINGS. THE ENGINEER CHECKED FIBER PORT LENS CELL AND BLAST SHIELD FOR DAMAGE - FOUND NO DAMAGE. THE LASER WAS FOUND TO HAVE MET ALL MANUFACTURER'S SPECIFICATIONS. THERE IS NO EVIDENCE THAT A LUMENIS PRODUCT HAD MALFUNCTIONED IN THIS EVENT, THOUGH A LUMENIS LASER SYSTEM WAS A CONTRIBUTORY PART OF THE EVENT. SINCE THIS EVENT LED TO A CANCELLED PROCEDURE, IN AN ABUNDANCE OF CAUTION LUMENIS IS REPORTING THIS EVENT AS LUMENIS BELIEVES THAT SUBJECTING A PATIENT TO ANOTHER ROUND OF ANESTHESIA CARRIES INHERENT RISKS.

    Description of Event or Problem · 1

    A USER FACILITY REPORTED THAT DURING A LITHOTRIPSY PROCEDURE IN WHICH A LUMENIS PULSE 100H AND NON-LUMENIS FIBER WERE BEING UTILIZED, THE LASER FIBER STOPPED WORKING IN THE MIDDLE OF THE PROCEDURE. A SCRUB TECH REACHED TO TIGHTEN THE FIBER CONNECTOR, WHICH WAS EXTREMELY HOT, AND SUSTAINED DISCRETE FIRST DEGREE BURNS TO THE DISTAL PHALANX ON THE PALMAR SURFACE OF THE THUMB, INDEX AND MIDDLE FINGER OF THE RIGHT HAND. THE LITHOTRIPSY PROCEDURE WAS SUBSEQUENTLY CANCELLED AND RESCHEDULED. NO REPORT OF PATIENT INJURY WAS RECEIVED, AND THE EVENT DID NOT CAUSE OR CONTRIBUTE TO ANY CHANGE IN THE PATIENT'S CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    992381 LUMENIS PULSE100H HOLMIUM (HO:YAG) SURGICAL LASERS AND DELIVERY DEVICE GEX LUMENIS LTD. LUMENIS PULSE 100H

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR