BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LUMENIS PULSE 120H

    MDR report key: 6348622 · Received February 22, 2017

    Report

    Report Number
    3004135191-2017-00024
    Event Type
    Injury
    Date Received
    February 22, 2017
    Date of Event
    February 9, 2016
    Report Date
    May 28, 2018
    Manufacturer
    LUMENIS, LTD
    Product Code
    GEX
    PMA / PMN Number
    K140388
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL MANUFACTURER NARRATIVE . DURING A RE-EVALUATION OF LUMENIS' REPORTABLE MALFUNCTION LIST (1008237_C) ON (B)(6) 2018 THIS EVENT WAS DETERMINED TO BE MDR REPORTABLE AS AN ADVERSE EVENT ONLY; INVESTIGATION RESULTS OF THE REPORTED EVENT CONCLUDED THAT NO LUMENIS PRODUCT PROBLEM/MALFUNCTION HAD OCCURRED. IT HAD ALSO BEEN CONCLUDED THAT THE MOST PROBABLE ROOT CAUSE OF THE EVENT WAS THE MALFUNCTION OF A NON-LUMENIS FIBER. BASED ON THAT, LUMENIS IS CHANGING THE TYPE OF REPORTED EVENT TO ADVERSE EVENT ONLY. ALTHOUGH THERE IS NO EVIDENCE THAT A LUMENIS PRODUCT HAD MALFUNCTIONED IN THIS EVENT, LUMENIS DETERMINED THAT THE ADVERSE EVENT IS STILL REPORTABLE AS A LUMENIS LASER SYSTEM WAS A CONTRIBUTORY PART OF THE EVENT. A HISTORICAL PRODUCT COMPLAINT REVIEW REVELED THAT IN MORE THAN TWO YEARS SINCE THIS REPORTED EVENT THERE HAVE BEEN NO OTHER REPORTS OF SERIOUS INJURY HAVING BEEN ASSOCIATED WITH THE OVERHEATING OF FIBER CONNECTORS. BASED ON THE INFORMATION ABOVE LUMENIS IS REMOVING THIS EVENT FROM ITS REPORTABLE MALFUNCTION LIST .

    Additional Manufacturer Narrative · 0

    DURING A RE-EVALUATION OF LUMENIS' REPORTABLE MALFUNCTION LIST (1008237_C) ON MAY-23-2018 THIS EVENT WAS DETERMINED TO BE MDR REPORTABLE AS AN ADVERSE EVENT ONLY; INVESTIGATION RESULTS OF THE REPORTED EVENT CONCLUDED THAT NO LUMENIS PRODUCT PROBLEM/MALFUNCTION HAD OCCURRED. IT HAD ALSO BEEN CONCLUDED THAT THE MOST PROBABLE ROOT CAUSE OF THE EVENT WAS THE MALFUNCTION OF A NON-LUMENIS FIBER. BASED ON THAT, LUMENIS IS CHANGING THE TYPE OF REPORTED EVENT TO ADVERSE EVENT ONLY. ALTHOUGH THERE IS NO EVIDENCE THAT A LUMENIS PRODUCT HAD MALFUNCTIONED IN THIS EVENT, LUMENIS DETERMINED THAT THE ADVERSE EVENT IS STILL REPORTABLE AS A LUMENIS LASER SYSTEM WAS A CONTRIBUTORY PART OF THE EVENT. A HISTORICAL PRODUCT COMPLAINT REVIEW REVEALED THAT IN MORE THAN TWO YEARS SINCE THIS REPORTED EVENT THERE HAVE BEEN NO OTHER REPORTS OF SERIOUS INJURY HAVING BEEN ASSOCIATED WITH THE OVERHEATING OF FIBER CONNECTORS. BASED ON THE INFORMATION ABOVE LUMENIS IS REMOVING THIS EVENT FROM ITS REPORTABLE MALFUNCTION LIST . CORRECTED DATA: ADVERSE EVENT ONLY.

    Additional Manufacturer Narrative · 1

    CORRECTION: ALTHOUGH THERE IS NO EVIDENCE THAT A LUMENIS PRODUCT HAD MALFUNCTIONED IN THIS EVENT, LUMENIS IS STILL REPORTING THIS EVENT AS A PRODUCT PROBLEM/MALFUNCTION SINCE A LUMENIS LASER SYSTEM WAS A CONTRIBUTORY PART OF THE ADVERSE EVENT. THIS FORM HAS BEEN CORRECTED TO NOW INCLUDE BOTH MALFUNCTION AND ADVERSE EVENT.

    Additional Manufacturer Narrative · 1

    THE INITIAL MDR FOR THIS EVENT HAD MISTAKENLY BEEN REPORTED AS A PRODUCT PROBLEM (MALFUNCTION) AND ADVERSE EVENT. LUMENIS HAS CHANGED THE REPORTED EVENT TO AN ADVERSE EVENT ONLY, AS THERE IS NO EVIDENCE THAT A LUMENIS PRODUCT HAD MALFUNCTIONED IN THIS CASE.

    Additional Manufacturer Narrative · 1

    LUMENIS INVESTIGATED THE EVENT REPORT CONTACTING THE USER FACILITY TO REQUEST ADDITIONAL EVENT INFORMATION WHICH WAS PROVIDED. USER FACILITY CONFIRMED THAT NO PATIENT INJURY WAS ASSOCIATED WITH THIS CASE, HOWEVER NO FURTHER INFORMATION WAS RECEIVED IN REGARDS TO THE ALLEGED INJURY OF THE STAFF MEMBER. LUMENIS WAS UNABLE TO CONFIRM THE SEVERITY OF THE BURN. AN EXAMINATION OF THE SUBJECT DEVICE BY A LUMENIS TECHNICAL EXPERT CONCLUDED THAT THE TWO SUBJECT FIBERS (200 AND 365) WERE BURNT AT THE PROXIMAL END WHICH CONNECTS TO THE LASER. IT WAS FURTHER REPORTED THAT THE TWO FIBERS WERE NON-LUMENIS FIBERS. THE TWO FIBERS WERE BOSTON SCIENTIFIC FIBERS, PART NUMBERS AND LOT NUMBERS WERE NOT REPORTED. THE LUMENIS TECHNICAL EXPERT EVALUATED THE DEVICE ON SITE AND FOUND A SLIGHT OPTICAL MISALIGNMENT. AFTER REALIGNMENT AND CALIBRATION OF THE DEVICE, THE LUMENIS TECHNICAL EXPERT FOUND THE LASER SYSTEM TO MEET MANUFACTURER'S PERFORMANCE SPECIFICATIONS AND FOUND TO BE SAFE TO USE. FURTHER EVALUATION BY LUMENIS R&D AND ENGINEERING SUGGESTED THAT THE SLIGHT OPTICAL MISALIGNMENT ISSUE COULD NOT HAVE BEEN THE CAUSE OF THE OVERHEATING OF THE 200 FIBER CONNECTOR. THE R&D AND ENGINEERING TEAM FURTHER EXPLAINED THAT THE LIKELIHOOD OF THE SAME EVENT TO HAPPEN WITH A LUMENIS 200 FIBER IS VERY REMOTE. "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 SIMILAR COMPLAINT SEARCH WAS PERFORMED IN LUMENIS' COMPLAINT MANAGEMENT SYSTEM, WHICH REVEALED NO EVENTS INVOLVING LUMENIS 200 FIBERS AND USERS BEING BURNED ON OVERHEATED LASER FIBER CONNECTORS HAD EVER BEEN REPORTED. LUMENIS HAS NOT REPORTED THIS EVENT TO BOSTON SCIENTIFIC AS THE USER FACILITY HAS CONFIRMED THAT BOSTON SCIENTIFIC REPRESENTATIVES WERE ALREADY AWARE OF THE FAULTY FIBERS, AND THE TWO FAULTY FIBERS HAVE BEEN SENT BACK TO BOSTON SCIENTIFIC. BASED ON THE INFORMATION ABOVE, THE MOST PROBABLE ROOT CAUSE OF THE EVENT WAS A MALFUNCTION OF THE NON-LUMENIS 200 FIBER. LUMENIS IS REPORTING THIS EVENT SINCE A LUMENIS LASER SYSTEM WAS A CONTRIBUTORY PART OF THE ADVERSE EVENT.

    Description of Event or Problem · 1

    A USER FACILITY REPORTED THAT A LASER TECHNICIAN SUSTAINED A BURN TO THE FINGER WHILE ATTEMPTING TO REMOVE A 200 LASER FIBER FROM A LUMENIS POWERSUITE LASER SYSTEM. USER FACILITY CONFIRMED THAT NO PATIENT INJURY WAS ASSOCIATED WITH THIS CASE, HOWEVER NO FURTHER INFORMATION WAS RECEIVED IN REGARDS TO THE ALLEGED INJURY OF THE STAFF MEMBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    132296 LUMENIS PULSE 120H HOLMIUMN (HO:YAG) SURGICAL LASERS AND DELIVERY DEVICE GEX LUMENIS, LTD LUMENIS PULSE 120H

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Other BOSTON SCIENTIFIC 200 HOLMIUM FIBER.