BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SLIMLINE 550¿ FIBER

    MDR report key: 7145460 · Received December 26, 2017

    Report

    Report Number
    3004135191-2017-00239
    Event Type
    Injury
    Date Received
    December 26, 2017
    Date of Event
    November 29, 2017
    Report Date
    December 26, 2017
    Manufacturer
    LUMENIS LTD.
    Product Code
    GEX
    PMA / PMN Number
    K140388
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2017, A LUMENIS SERVICE ENGINEER JOINED AN ON-SITE INSPECTION OF THE LASER SYSTEM AND DELIVERY DEVICE WHICH HAD BEEN USED DURING THE EVENT. AN EVALUATION OF THE LASER SYSTEM BY A LUMENIS SERVICE ENGINEER FOUND THE SYSTEM OPERATED ACCORDING TO MANUFACTURE SPECIFICATIONS. SYSTEM MALFUNCTION IS NOT SUSPECTED TO BE THE CAUSE OF THE EVENT. ACCORDING TO THE FACILITY'S LASER SPECIALIST, "A CONCEIVABLE CAUSE OF THE BREAKAGE SEEMED SOME PHYSICAL POWER MIGHT HAVE BROKEN IT, BUT HOW IT HAPPENED WAS UNCLEAR." A LUMENIS SALES MANAGER REQUESTED THE BROKEN FIBER TO BE RETURNED TO LUMENIS FOR ANALYSIS, BUT THE COMPLAINANT REFUSED TO RETURN THE FIBER; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. 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. 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. 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. OTHER THAN THE INCIDENT REPORT AND REPORT FROM THE ONSITE INSPECTION, LUMENIS HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE; A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A FOREIGN USER FACILITY REPORTED THAT WHILE USING A LUMENIS VERSAPULSE POWERSUITE 80/100 CONSOLE WITH A LUMENIS SLIMLINE 550¿ LASER FIBER DURING A CIN PROCEDURE, THE FIBER BROKE AFTER FIFTEEN MINUTES OF LASING. LASER ENERGY HAD ESCAPED THE BROKEN PART OF THE FIBER BURNING THE DRAPE OVER THE PATIENT, AND SUBSEQUENTLY BURNING THE PATIENT ON THE INSIDE OF THE RIGHT KNEE. THE SEVERITY OF THE BURN HAD NOT BEEN REPORTED, HOWEVER IT HAD BEEN REPORTED THAT THE BURN WAS TREATED AFTER THE PROCEDURE, AND THE FACILITY DOES NOT EXPECT ANY PERMANENT DAMAGE SUFFERED AS A RESULT OF THE INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    926032 SLIMLINE 550¿ FIBER POWERED LASER SURGICAL INSTRUMENT GEX LUMENIS LTD. SLIMLINE 550¿ FIBER 60940216

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Other