BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUMENIS PULSE 100H

    MDR report key: 8631216 · Received May 22, 2019

    Report

    Report Number
    3004135191-2019-00060
    Event Type
    Malfunction
    Date Received
    May 22, 2019
    Date of Event
    April 25, 2019
    Report Date
    May 22, 2019
    Manufacturer
    LUMENIS LTD.
    Product Code
    GEX
    UDI-DI
    07290109140520
    PMA / PMN Number
    K170121
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A TWO YEAR HISTORICAL REVIEW OF SIMILAR PRODUCT COMPLAINTS REVEALED ONLY TWO (2) REPORTS OF BLOWN F8 FUSES BEING REPORTED TO LUMENIS, NONE OF WHICH LED TO SERIOUS INJURY. TO DATE LUMENIS IS UNAWARE OF SUCH EVENTS EVER HAVING LED TO INJURY. ALTHOUGH THERE WAS NO REPORT OF INJURY ASSOCIATED WITH THIS EVENT, LUMENIS BELIEVES THAT HAD A LUMENIS SERVICE ENGINEER NOT BEEN PRESENT AT THE TIME OF THE EVENT TO REPLACE THE FUSE, THE PROCEDURE COULD HAVE BEEN CANCELLED AND THE PATIENT AWAKENED FROM ANESTHESIA. LASER SYSTEM MALFUNCTION IS NOT THE SUSPECTED CAUSE OF THE EVENT REPORTED. LUMENIS HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THE EVENT TO DATE, BUT BASED ON THE INFORMATION AT HAND, LUMENIS BELIEVES THAT THE MOST PROBABLE CAUSE OF THE EVENT WAS A SUDDEN POWER SURGE FROM THE FACILITY'S ELECTRICAL INFRASTRUCTURE. IN AN ABUNDANCE OF CAUTION LUMENIS IS REPORTING THIS EVENT; SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE; A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A FOREIGN FACILITY REPORTED THAT DURING A PROCEDURE IN WHICH A LUMENIS PULSE 100 WAS BEING UTILIZED THE SYSTEM SUDDENLY "STOPPED WORKING". A LUMENIS SERVICE ENGINEER, WHO WAS PRESENT DURING THE PROCEDURE, INSPECTED THE SYSTEM AND FOUND THE F8 FUSE WAS BLOWN. THE ENGINEER OPENED THE SYSTEM, REPLACED THE FUSE, AND THE SYSTEM WAS RETURNED TO COMPLETE THE PROCEDURE AFTER A SLIGHT DELAY. NO REPORT OF PATIENT INJURY OR HARM WAS RECEIVED, NOR DID THE EVENT CAUSE OR CONTRIBUTE TO ANY CHANGE IN THE PATIENT'S STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    425878 LUMENIS PULSE 100H HOLMIUM (HO:YAG) SURGICAL LASERS AND DELIVERY DEVICE GEX LUMENIS LTD. LUMENIS PULSE 100H 07290109140520

    Patients

    Seq Age Sex Outcome Treatment
    1