BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SLIMLINE FIBER

    MDR report key: 7078390 · Received December 4, 2017

    Report

    Report Number
    3004135191-2017-00223
    Event Type
    Injury
    Date Received
    December 4, 2017
    Date of Event
    November 7, 2017
    Report Date
    December 4, 2017
    Manufacturer
    LUMENIS LTD.
    Product Code
    GEX
    PMA / PMN Number
    K140388
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    SERVICE PERSONNEL

    Narratives

    Additional Manufacturer Narrative · 1

    LUMENIS INVESTIGATED THE REPORTED EVENT BY CONTACTING ITS FOREIGN DISTRIBUTOR TO REQUEST ADDITIONAL INFORMATION. AN INCIDENT REPORT HAD BEEN PROVIDED WITH LIMITED INFORMATION. A LUMENIS CERTIFIED SERVICE TECHNICIAN WHO WAS PRESENT DURING THE PROCEDURE CONCLUDED THAT THE INCIDENT WAS DUE TO "USER MISHANDLING" AS THE PHYSICIAN HAD PINCHED THE FIBER AT THE ENTRANCE OF THE CYSTOSCOPE, WHILE SIMULTANEOUSLY GENERATING MOVEMENTS WITH THE RESECTOR. ALTHOUGH THE SUSPECTED DEVICE HAD NOT BEEN KEPT BY THE FACILITY AND NOT RETURNED TO LUMENIS FOR EVALUATION, LUMENIS BELIEVES THAT DEVICE MALFUNCTION IS NOT SUSPECTED AS BEING THE CAUSE OR CONTRIBUTORY TO THE EVENT REPORTED. THE MOST PROBABLE ROOT CAUSE IS "OPERATIONAL CONTEXT CAUSED OR CONTRIBUTED TO EVENT", LUMENIS BELIEVE THE PROBLEM WAS RELATED TO THE OPERATOR'S TECHNIQUE OR USE ENVIRONMENT, CAUSED BY THE USER PINCHING THE FIBER AT THE ENTRANCE OF THE CYSTOSCOPE WHILE MOVING THE RESECTOR. ALTHOUGH THE SEVERITY OF THE BURN WAS NOT CONFIRMED, LUMENIS CANNOT RULE OUT THAT A SERIOUS INJURY HAD OCCURRED, AND IN AN ABUNDANCE OF CAUTION, LUMENIS IS REPORTING THIS AS AN ADVERSE EVENT.

    Description of Event or Problem · 1

    A FOREIGN USER FACILITY REPORTED THAT DURING A HOLEP PROCEDURE IN WHICH AN UNSPECIFIED LUMENIS FIBER DELIVERY DEVICE HAD BEEN USED, THE FIBER HAD BROKEN, SUBSEQUENTLY BURNING THE FINGER OF THE PHYSICIAN. THE BREAK WAS AT THE ENTRANCE OF THE FIBER TO THE CYSTOSCOPE. THE FIBER WAS REPLACED WITH ANOTHER FIBER, AND IT TOO HAD BROKEN AT THE SAME PLACE. NO REPORT OF BURN CAUSED BY THE SECOND FIBER BREAK. THE PROCEDURE WAS COMPLETED BY USING A THIRD FIBER WITH NO REPORT OF PATIENT INJURY HAVING BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    859532 SLIMLINE FIBER POWERED LASER SURGICAL INSTRUMENT GEX LUMENIS LTD. SLIMLINE FIBER

    Patients

    Seq Age Sex Outcome Treatment
    1 Other