BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSAPULSE POWERSUITE 60W

    MDR report key: 14268421 · Received May 3, 2022

    Report

    Report Number
    1720381-2022-00004
    Event Type
    Injury
    Date Received
    May 3, 2022
    Date of Event
    February 4, 2020
    Report Date
    May 2, 2022
    Manufacturer
    LUMENIS LTD
    Product Code
    GEX
    UDI-DI
    07290109140575
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    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 THIS EXEMPTION WAS REVOKED EFFECTIVE JUNE 30, 2019.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 MEDWATCH REPORT REGARDING AN INCIDENT THAT OCCURRED ON (B)(6) 2020. LUMENIS CONTACTED THE USER FACILITY DIRECTLY TO OBTAIN ADDITIONAL INFORMATION. AN INCIDENT FORM WAS PROVIDED. IT HAD BEEN CONFIRMED BY THE USER FACILITY THAT DURING A FLEXIBLE BRONCHOSCOPY WITH BIOPSY UNDER GENERAL ANESTHESIA TISSUE SAMPLE WAS OBTAINED, AND PATIENT DEVELOPED BLEEDING. LUMENIS VPPS 60W (0638-804-01:529) LASER WAS BEING UTILIZED WITH A NON-LUMENIS FIBER SU 200UM PRIVATE LABEL (LOT# C000008254), TO CAUTERIZE THE BLEEDING OF THE TUMOR. ANESTHESIA DECREASED THE OXYGEN TO 21% AND THE LASER WAS USED. THERE WAS A SMALL SPARK AND PIECE OF TISSUE APPEARED TO BE HEATED AND IT SLOWLY MELTED THE DISTAL END OF THE BRONCHOSCOPE. LARGE COLD SALINE WAS INJECTED AND BRONCHOSCOPE WAS REMOVED. NEW BRONCHOSCOPE WAS INSERTED AND THERE WERE NO AIRWAY DAMAGE. AREA WAS IRRIGATED AND PROCEDURE WAS COMPLETED. PATIENT TRANSFERRED TO THE ICU FOR OVERNIGHT MONITORING AND DISCHARGED TO HOME ON (B)(6) 2020 WITH NO PERMANENT DAMAGE AS A RESULT OF THE INJURY. LUMENIS IS NOT THE MANUFACTURER OF THE FIBER THAT WAS USED IN THIS EVENT. THE MANUFACTURER OF THE FIBER HAS BEEN MADE AWARE OF THE THIS INCIDENT. A LUMENIS CLINICAL MANAGER HAD REVIEWED THIS REPORTED EVENT AND DETERMINED THAT A SMALL SPARK IS AN EXPECTED SIDE EFFECT DUE TO USER MISUSE ALREADY KNOWN AS LASER TECHNOLOGY RISK. THE CLINICAL MANAGER STATED THAT " IN THESE KIND OF PROCEDURE, WHILE INTUBATION IS IN USE, SPECIAL CARE SHOULD BE TAKEN FOR PRESENCE OF OXYGEN IN THE SURGICAL FIELD DUE TO THE FLAMMABILITY. LEVEL OF OXYGEN SHOULD BE MONITORED BY THE PROFESSIONAL OR PERSONNEL." A REVIEW OF SUBJECT DEVICE LABELING (0637-117-01DE-L_B) STATED THE FOLLOWING: "FLASH FIRE MAY OCCUR. FLAMMABLE INHALATION GENERAL ANESTHETICS MUST NOT BE USED. OXYGEN LEVELS IN THE DIRECT SURGICAL AREA MUST NOT EXCEED 50 PERCENT. THE RISKS OF COMBUSTION, PERFORATION, AND LASER-INDUCED HEMORRHAGE, ANY OF WHICH COULD CAUSE DEATH, MUST BE FULLY EXPLAINED TO THE PATIENT." A REVIEW OF SYSTEM RISK FILES FOUND THE RISK OF FIRE ((B)(4)) WHICH HAS THE POTENTIAL TO LEAD TO BURNS OR SMOKE INHALATION/ SERIOUS INJURY REQUIRING SURGICAL INTERVENTION /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. THERE WAS NO REPORT OF DEVICE MALFUNCTION DURING THE PROCEDURE. AFTER THE INCIDENT THE USER FACILITY REPLACED THE BRONCHOSCOPE AND COMPLETED THE OPERATION WITH THE SAME LUMENIS VPPS 60W. 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. 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 JUNE 24, 2020 LUMENIS RECEIVED A USER SUBMITTED MEDWATCH REPORT # (B)(4) IN WHICH THE DESCRIPTION OF THE EVENT READS: "A BRONCHOSCOPY FOR A TUMOR BIOPSY WAS BEING PERFORMED. TISSUE SAMPLE WAS OBTAINED, AND PATIENT DEVELOPED BLEEDING. A LUMENIS VERSAPULSE POWERSUITE 60W WAS BEING UTILIZED WITH A NON-LUMENIS FIBER TO CAUTERIZE THE BLEEDING OF THE TUMOR. ANESTHESIA DECREASED THE OXYGEN TO 21% AND THE LASER WAS USED. A SPARK/FLAME WAS NOTED, AND STERILE WATER WAS IMMEDIATELY FLUSHED THROUGH THE BRONCHOSCOPE AND BRONCHOSCOPE WAS PULLED OUT IMMEDIATELY".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1244408 VERSAPULSE POWERSUITE 60W POWERED LASER SURGICAL INSTRUMENT GEX LUMENIS LTD VERSAPULSE POWERSUITE 60W 07290109140575

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention| H