BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    M22

    MDR report key: 8023399 · Received October 31, 2018

    Report

    Report Number
    3004135191-2018-00138
    Event Type
    Malfunction
    Date Received
    October 31, 2018
    Date of Event
    July 12, 2018
    Report Date
    June 13, 2019
    Manufacturer
    LUMENIS LTD.
    Product Code
    GEX
    PMA / PMN Number
    K170060
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    LUMENIS DETERMINED THE REPORTED EVENT TO BE A SITUATION IN WHICH AN IPL FILTER WAS WRONGLY RECOGNIZED BY THE SYSTEM DUE TO A MALFUNCTION IN ONE OR MORE OF ITS FOUR OPTICAL SENSORS (RESPONSIBLE FOR FILTER IDENTIFICATION). A REVIEW OF THE SUBJECT DEVICE RISK FILES (B)(4) IDENTIFIED THE RISK OF "WRONG TIP/LIGHT-GUIDE/FILTER INSERTION TO HEAD" WHICH MAY LEAD TO 'TISSUE DAMAGE, BURNS'. THE RISK, ALTHOUGH SIMILAR, FAILED TO IDENTIFY THE SPECIFIC FAILURE MODE OF 'SENSOR FAILURE'; LUMENIS CONDUCTED AN HHE TO DETERMINE A NEW HAZARD/RISK INDEX WHICH WOULD INCLUDE THE NEW FAILURE MODE. AS PART OF THE HHE, COMPLAINTS SINCE THE PRODUCT WERE LAUNCHED (JULY 2015) WERE COMPILED AND REVIEWED TO DETERMINE IF THERE IS ANY CONNECTION BETWEEN FILTER MIS-IDENTIFICATION AND HARM. NINE (9) SAFETY COMPLAINTS WERE IDENTIFIED AS BEING THE RESULT OF INCORRECT FILTER IDENTIFICATION. OF THE NINE (9) COMPLAINTS, TWO (2) WERE IDENTIFIED AS BEING POSSIBLY RELATED TO THE NEW FAILURE MODE. IN NONE OF THE AFOREMENTIONED COMPLAINTS DID A CONFIRMED 'SERIOUS INJURY' OCCUR. THE HHE CONCLUDED THAT THE RISK SEVERITY OF 'MISIDENTIFIED FILTERS' IS NO MORE THAN MARGINAL WHICH MAY CAUSE TRANSIENT MINOR INJURY TO A PATIENT OR USER. ALTHOUGH THE MALFUNCTION HAS BEEN DETERMINED TO NOT LIKELY LEAD TO SERIOUS INJURY SHOULD IT OCCUR, LUMENIS HAS INITIATED CAPA # (B)(4) TO FURTHER INVESTIGATE THE "FILTER MIS-RECOGNITION" ISSUES AND DETERMINE CORRECTIVE ACTION.

    Additional Manufacturer Narrative · 1

    LUMENIS INVESTIGATED THE REPORTED EVENT BY CONTACTING THE USER FACILITY DIRECTLY. ONE (1) ATTEMPT TO OBTAIN; PATIENTS TREATMENT SETTINGS, PATIENTS INFORMATION, PATIENTS PHOTOS, AND SUN EXPOSURE, WHICH WERE PARTLY PROVIDED, EXCEPT FOR PATIENT PHOTOGRAPHS. AN EXAMINATION OF THE SUBJECT DEVICE BY A LUMENIS TECHNICAL EXPERT CONCLUDED THAT SYSTEM WASN'T RECOGNIZING THE FILTERS CORRECTLY. THE EXPERT REPLACED THE HAND PIECE AFTER WHICH HE CHECKED CALIBRATION AND ENERGY OUTPUT VERIFICATION. FOLLOWING THIS, THE SUBJECT DEVICE OPERATED WELL WITHIN MANUFACTURE SPECIFICATIONS AND THE TECHNICAL EXPERT CONFIRMED THAT THE SYSTEM PROPERLY IDENTIFIED VARIOUS FILTERS TESTED. LUMENIS IS CURRENTLY INVESTIGATING THE REPORTED EVENT. AT THIS POINT LUMENIS CAN NOT RULE OUT THAT A MALFUNCTION HAD OCCURRED AND CAN NOT RULE IF THIS MALFUNCTION WOULD LIKELY LEAD TO DEATH OR SERIOUS INJURY SHOULD IT RECUR. HENCE, IN AN ABUNDANCE OF CAUTION, LUMENIS IS REPORTING THIS EVENT. WHEN ADDITIONAL INFORMATION IS PROVIDED TO LUMENIS WITH WHICH TO DETERMINE A CAUSE FOR THE REPORTED EVENT, LUMENIS WILL FILE A FOLLOW-UP MDR.

    Description of Event or Problem · 1

    A USER FACILITY REPORTED THAT ONE (1) PATIENT DEVELOPED BLISTERS FOLLOWING IPL TREATMENT WITH A LUMENIS M22 LASER. SYSTEM HAS FAILED TO PROPERLY IDENTIFY IPL FILTERS USED WITH IPL HANDPIECE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    865979 M22 INTENSE PULSE LIGHT DELIVERY DEVICE GEX LUMENIS LTD. M22

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other