BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOSES 200¿ D/F/L DISPOSABLE FIBER

    MDR report key: 14268387 · Received May 3, 2022

    Report

    Report Number
    1720381-2022-00005
    Event Type
    Injury
    Date Received
    May 3, 2022
    Date of Event
    August 20, 2020
    Report Date
    May 2, 2022
    Manufacturer
    LUMENIS LTD
    Product Code
    GEX
    UDI-DI
    07290109143170
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INITIAL REPORT WAS SUBMITTED UNDER EXEMPTION # E2017002 ONLY UNDER THE MFR REGISTRATION NUMBER OF LUMENIS LTD (THE MANUFACTURER), (B)(4). THIS EXEMPTION WAS REVOKED EFFECTIVE JUNE 30, 2019. THEREFORE, THE CURRENT SUPPLEMENTAL REPORT IS INTENDED TO COVER THE REPORTING REQUIREMENT OF THE SAME REPORTABLE EVENT FOR LUMENIS INC., THE IMPORTER, UNDER REGISTRATION NO. (B)(4). LUMENIS RECEIVED A REPORT REGARDING AN INCIDENT THAT OCCURRED DURING A PROCEDURE IN WHICH A LUMENIS PULSE 120 LASER AND MOSES 200 FIBER WERE UTILIZED. IT APPEARED, THE PHYSICIAN LOST VISIBILITY DUE TO STONE DUST (OPINION OF THE REPORTER THAT OBSERVED THE EVENT) AND HIT THE URETHRAL WALL WITH THE LASER FIBER CAUSING A PERFORATION. PERFORATION WAS NOT CAUSED BY MALFUNCTION OF THE LASER OR LASER FIBER. THE PHYSICIAN USED A STENT IN ORDER TO HEAL THE URETER. PATIENT IS EXPECTED TO FULLY RECOVER. A REVIEW OF SYSTEM RISK FILES (RD-1124690_AJ) REVEALED RISK #4.2.1; USER LASES AT UNDESIRED LOCATION WHICH HAS THE POTENTIAL TO LEAD TO PERMANENT INJURY RESULTING IN PERMANENT IMPAIRMENT. THE RISK LIKELIHOOD HAS BEEN QUANTIFIED AND FOUND TO BE REMOTE, AND THE RISK HAS BEEN CHARACTERIZED AND DOCUMENTED AS ACCEPTABLE WITHIN FULL RISK ASSESSMENT. A REVIEW OF SUBJECT DEVICE LUMENIS P120 LABELING (UM_10012510_K) REVEALED THE FOLLOWING: "THE LASER SHOULD BE USED ONLY ON TISSUES THAT ARE FULLY OBSERVABLE. DO NOT USE THE LASER IF THE DESIRED TARGET IS NOT VISIBLE. ALL AVAILABLE MEASURES TO VISUALIZE THE TARGET TISSUE SHOULD BE TAKEN". LUMENIS CLINICAL EXPERT INDICATED THAT IT IS MOST LIKELY A USER ERROR, OPERATING THE LASER WITHOUT SUFFICIENT VISIBILITY. THE SYSTEM IS EQUIPPED WITH AIMING BEAM AND THE OPERATOR MANUAL INSTRUCTS THE USER ABOUT THE PROPER USE OF THE SYSTEM AND COMPONENTS. IN THIS CASE OF PERFORATION, THE USER DID NOT HAVE A FULL VIEW OF THE TARGET TISSUE, YET CONTINUED TO FIRE THE LASER, TILL IT HIT UN-DESIRED TISSUE AND DAMAGED THE WALL. LUMENIS BELIEVES THAT DEVICE MALFUNCTION IS NOT SUSPECTED AS BEING THE CAUSE OR CONTRIBUTORY TO THE EVENT REPORTED. A REVIEW AND ANALYSIS OF ALL AVAILABLE INFORMATION INDICATED THAT THE MOST PROBABLE ROOT CAUSE IS "OPERATIONAL CONTEXT". LUMENIS BELIEVES THE PROBLEM WAS RELATED TO THE OPERATOR'S TECHNIQUE OR USE ENVIRONMENT. ALTHOUGH THERE IS NO EVIDENCE THAT A LUMENIS PRODUCT HAD MALFUNCTIONED IN THIS EVENT, THE EVENT CAUSED AN INJURY TO A PATIENT. THE PHYSICIAN PLACED A STENT IN ORDER TO PRECLUDE A PERMANENT INJURY AND/OR A LIFE THREATENING SITUATION. IN AN ABUNDANCE OF CAUTION, LUMENIS DETERMINED THAT THIS EVENT IS STILL REPORTABLE AS A LUMENIS LASER SYSTEM WAS A CONTRIBUTORY PART OF THE EVENT. LUMENIS IS CLOSING THIS COMPLAINT, BUT WILL CONTINUE TO MONITOR THIS OPERATIONAL CONTEXT FAILURE; 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

    ON (B)(6) 2020 LUMENIS RECEIVED A BSC REPORT (B)(4) REGARDING AN INCIDENT THAT OCCURRED ON (B)(6) 2020. IT WAS REPORTED THAT DURING A URETEROSCOPY WITH LASTER LITHOTRIPSY POSSIBLE TURBT AND STENT EXCHANGE PROCEDURE IN WHICH A LUMENIS PULSE 120 LASER AND MOSES 200 FIBER WERE UTILIZED, "IT APPEARED THE PHYSICIAN LOST VISIBILITY DUE TO STONE DUST (OPINION OF THE REPORTER THAT OBSERVED THE EVENT) AND HIT THE URETHRAL WALL WITH THE LASER FIBER CAUSING A PERFORATION. PERFORATION NOT CAUSED BY MALFUNCTION OF THE LASER OR LASER FIBER. THE PHYSICIAN STENTED THE PATIENT TO HEAL THE URETER AND RE-VISIT STONE AT LATER DATE. PATIENT IS EXPECTED TO FULLY RECOVER."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1500786 MOSES 200¿ D/F/L DISPOSABLE FIBER LASER FIBER DELIVERY DEVICE, PRODUCT CODE GEX LUMENIS LTD MOSES 200¿ D/F/L DISPOSABLE 56590520 07290109143170

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other