BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LUMENIS PULSE 120H

    MDR report key: 14268414 · Received May 3, 2022

    Report

    Report Number
    1720381-2022-00003
    Event Type
    Injury
    Date Received
    May 3, 2022
    Date of Event
    November 21, 2019
    Report Date
    May 2, 2022
    Manufacturer
    LUMENIS LTD
    Product Code
    GEX
    UDI-DI
    07290109140513
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    CA, 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 THIS EXEMPTION WAS REVOKED EFFECTIVE JUNE 30, 2019.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 CONTACTED THE USER FACILITY TO REQUEST ADDITIONAL INFORMATION; AN INCIDENT REPORT WAS PROVIDED. ACCORDING TO THE INFORMATION RECEIVED A NON-LUMENIS FIBER MELTED MID-CASE AT THE CONNECTION POINT. WHEN THE NURSE WENT TO REMOVE THE FIBER SHE FELT A BURNING SENSATION ON HER RIGHT INDEX FINGER AND THUMB. THE SURGEON TURNED THE MACHINE OFF AND THE NURSE LEFT THE ROOM TO PUT ICE ON HER FINGER AND GO TO OCCUPATIONAL HEALTH WHERE SHE WAS GIVEN SILVADENE OINTMENT AND FINGER WAS WRAPPED IN GAUZE AND TAPE. ACCORDING TO THE INCIDENT FORM, THE NURSE HAS GOT A SMALL SCAR. THE PROCEDURE WAS COMPLETED WITH ANOTHER FIBER. LUMENIS IS NOT THE MANUFACTURER OF THE FIBER WHOSE FIBER CONNECTOR WAS REPORTED TO HAVE OVERHEATED IN THIS EVENT. 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 PI-1502103502490/(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 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. DEVICE WAS MANUFACTURED 04-FEB-2018 AND INSTALLED AT THE CUSTOMERS SITE ON (B)(6) 2018. A LUMENIS SERVICE ENGINEER VISITED THE SITE AFTER THE REPORTED EVENT. THE ENGINEER CHECKED ALIGNMENT TO FIBER PORT AND FOUND THAT ALL LASERS ARE EXACTLY CENTERED ON FIBER, INSPECTED THE LASER'S BLAST SHIELD AND FOUND IT WAS PITTED. REPLACED BLAST SHIELD AND ONCE AGAIN CONFIRMED ALIGNMENT TO FIBER PORT. FILLED SYSTEM WITH COOLANT TO MAXIMUM LEVEL AND CONFIRMED ALL COOLING FUNCTIONS. CHECKED ENERGY CALIBRATION AT VARIOUS SETTINGS TO ENSURE PROPER ENERGY DELIVERY. CHECKED SAFETY, MECHANICAL AND INTERFACE FUNCTIONS. VERIFIED ALL SYSTEM OPERATIONS. THE SYSTEM PASSED ALL OF THE OPERATIONAL AND SAFETY TESTS AND WAS FOUND TO HAVE MET MANUFACTURER'S SPECIFICATIONS. ALTHOUGH THERE IS NO EVIDENCE THAT A LUMENIS PRODUCT HAD MALFUNCTIONED IN THIS EVENT, AND THE INCIDENT DID NOT CAUSE OR CONTRIBUTE TO ANY CHANGE IN THE PATIENT'S CONDITION, THE EVENT CAUSED A MINOR INJURY, SMALL SCAR, TO STAFF. 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 FAILURE MODE; COMPLAINT TRENDING WILL CONTINUE TO MONITOR PER GLOBAL COMPLAINT HANDLING SOP (DOC NO. 34-01-04-00) AND PER POST MARKETING SURVEILLANCE PROCEDURE (DOC NO. 1005539).

    Description of Event or Problem · 0

    A USER FACILITY REPORTED THAT DURING A PROCEDURE IN WHICH A LUMENIS PULSE 120H LASER WAS BEING UTILIZED WITH A NON-LUMENIS FIBER, THE FIBER MELTED MID-CASE AT THE CONNECTION POINT. WHEN THE NURSE WENT TO REMOVE THE FIBER SHE FELT A BURNING SENSATION ON HER RIGHT INDEX FINGER AND THUMB. THE SURGEON TURNED THE MACHINE OFF AND THE NURSE LEFT THE ROOM TO PUT ICE ON HER FINGER AND GO TO OCCUPATIONAL HEALTH WHERE SHE WAS GIVEN SILVADENE OINTMENT AND FINGER WAS WRAPPED IN GAUZE AND TAPE. NO REPORT OF PATIENT INJURY OR COMPLICATIONS WAS RECEIVED AS THE PROCEDURE WAS COMPLETED WITH ANOTHER FIBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1244401 LUMENIS PULSE 120H HOLMIUM (HO:YAG) SURGICAL LASERS AND DELIVERY DEVICE GEX LUMENIS LTD LUMENIS PULSE 120H 07290109140513

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other