BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGHTSHEER DESIRE

    MDR report key: 6683783 · Received July 3, 2017

    Report

    Report Number
    3004135191-2017-00088
    Event Type
    Malfunction
    Date Received
    July 3, 2017
    Date of Event
    June 2, 2017
    Report Date
    October 25, 2017
    Manufacturer
    LUMENIS, LTD.
    Product Code
    GEX
    PMA / PMN Number
    K151947
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LUMENIS INVESTIGATED THE REPORTED EVENT BY CONTACTING THE USER FACILITY DIRECTLY TO OBTAIN PATIENT INFORMATION, TREATMENT SETTINGS, AND PATIENT PHOTOGRAPHS, WHICH WERE PROVIDED EXCEPT FOR PATIENT PHOTOGRAPHS. AN EXAMINATION OF THE SUBJECT DEVICE BY A LUMENIS TECHNICAL EXPERT STATED, "NO ERROR ON STARTUP. XC ENERGY OUTPUT IS WITHIN FACTORY SPECIFICATIONS. PERFORMED FULL EVALUATION AND FOUND LIGHSHEER XC HEAD EPI TEMPERATURE SETTINGS IS BELOW SPECIFICATION AND DELTA T DID NOT CORRECT THE ISSUE. DIODE TEMPERATURE IS OUT OF SPECIFICATIONS. CE ALSO FOUND DEFECTIVE SPOT ON XC OUTPUT WINDOW." THE TECHNICAL EXPERT RECOMMENDED A REPLACEMENT HANDPIECE TO THE USER FACILITY. A LUMENIS CLINICAL DIRECTOR REVIEWED THE REPORTED EVENT DETAILS, AND PATIENT TREATMENT SETTINGS CONCLUDING THE TREATMENT SETTINGS USED WERE WITHIN NORMAL LIMITS BASED ON COMMON MEDICAL PRACTICE, DEVICE TRAINING, AND DEVICE LABELING. IT WAS FURTHER DETERMINED THAT THE COMPLETE RESOLUTION OF ERYTHEMA WOULD BE INDICATIVE OF COMMON SIDE EFFECTS AS LISTED IN THE PRODUCT USER MANUAL. A REVIEW OF DEVICE LABELING STATES: "THE MOST COMMON IMMEDIATE RESPONSES OF LASER TREATMENT FOR HAIR REMOVAL, VASCULAR LESIONS, PIGMENTED LESIONS ARE ERYTHEMA, EDEMA (REDNESS AND SWELLING), PERIFOLLICULAR EDEMA AND PERIVASCULAR EDEMA, VASCULAR BLEACHING, LIGHTENING/DARKENING OF PIGMENT WHICH MAY OCCUR IMMEDIATELY AFTER LASER TREATMENT AND TYPICALLY RESOLVE WITHIN A FEW DAYS. IF EXCESSIVE OR PROLONGED EDEMA OR ERYTHEMA OCCURS, THEY ARE CONSIDERED ADVERSE EFFECTS."

    Additional Manufacturer Narrative · 1

    ADDITIONAL / CORRECTED INFO : TEMPERATURE ISSUE: A REVIEW OF LIGTHSHEER DESIRE PRODUCT RISK FILES SHOWS THIS IS AN ANTICIPATED RISK (# 12.1.1.1 IN RISK FILE 1000577_J) WHICH HAS BEEN QUANTIFIED AND FOUND LIKELY TO LEAD TO A SERIOUS INJURY IF THE MALFUNCTION WERE TO RECUR. THEREFORE, THIS EVENT HAS BEEN DETERMINED TO BE REPORTABLE PER MDR DECISION TREE. THE RISK HAS BEEN CHARACTERIZED AND DOCUMENTED AS ACCEPTABLE WITHIN A FULL RISK ASSESSMENT, THEREFORE NO CORRECTIVE AND/OR PREVENTIVE ACTIONS ARE REQUIRED. SPOTS ON THE INNER SIDE OF THE SAPPHIRE ISSUE: A LUMENIS CLINICAL MANAGER, HAVING ALREADY CONDUCTED INVESTIGATIONS OF SIMILAR REPORTED EVENTS, HAD CONCLUDED "IN CASE OF SPOTS ON THE INNER SIDE OF THE SAPPHIRE, THE OUTPUT FLUENCE WOULD BE LOWER THAN EXPECTED AND WOULD NOT LEAD TO CHILLED SAPPHIRE OVERHEATING NOR HOT SPOTS ON THE OUTER SIDE (THE SIDE IN CONTACT WITH THE PATIENT). THUS THIS MALFUNCTION WOULD NOT LEAD TO SERIOUS INJURY SHOULD THE MALFUNCTION RECUR." THE MDR FOR THIS EVENT HAD INITIALLY BEEN REPORTED AS A PRODUCT PROBLEM (MALFUNCTION) AND ADVERSE EVENT (SERIOUS INJURY). BASED ON LUMENIS' FURTHER EVALUATION OF THIS EVENT, THE PRODUCT PROBLEM (MALFUNCTION) WAS REMOVED BY MISTAKE FROM THE FIRST FOLLOW UP REPORT OF THIS EVENT. SINCE THERE IS NO EVIDENCE THAT A SERIOUS INJURY HAD OCCURED IN THIS CASE, LUMENIS IS WITHDRAWING THE ADVERSE EVENT CLAIM. LUMENIS HAS CHANGED THE REPORT TYPE OF THIS MDR REPORT TO BE A MALFUNCTION ONLY.

    Additional Manufacturer Narrative · 1

    LUMENIS INVESTIGATED THE REPORTED EVENT BY CONTACTING THE USER FACILITY DIRECTLY TO OBTAIN PATIENT INFORMATION, TREATMENT SETTINGS, AND PATIENT PHOTOGRAPHS. FOLLOWING THREE (3) ATTEMPTS BY PHONE (JUNE 8, 19, 26), NO ADDITIONAL INFORMATION HAS BEEN PROVIDED. AN EXAMINATION OF THE SUBJECT DEVICE BY A LUMENIS TECHNICAL EXPERT STATED, "NO ERROR ON STARTUP. XC ENERGY OUTPUT IS WITHIN FACTORY SPECIFICATIONS. PERFORMED FULL EVALUATION AND FOUND LIGHSHEER XC HEAD EPI TEMPERATURE SETTINGS IS BELOW SPECIFICATION AND DELTA T DID NOT CORRECT THE ISSUE. DIODE TEMPERATURE IS OUT OF SPECIFICATIONS. CE ALSO FOUND DEFECTIVE SPOT ON XC OUTPUT WINDOW." THE TECHNICAL EXPERT RECOMMENDED A REPLACEMENT HANDPIECE TO THE USER FACILITY. NO TREATMENT SETTINGS OR PATIENT PHOTOGRAPHS WERE PROVIDED BY THE USER FACILITY; THEREFORE, A CLINICAL REVIEW OF THE TREATMENT SETTINGS CANNOT BE PERFORMED. BASED ON THE INFORMATION PROVIDED BY THE USER FACILITY A ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME. LUMENIS IS CONTINUING ITS INVESTIGATION AND WILL FILE A FOLLOW UP MDR WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    A USER FACILITY REPORTED THAT ONE (1) PATIENT HAD HAIR REMOVAL TREATMENT ON THE UPPER LIP, UNDER ARMS, LOWER LEGS, AND BIKINI RESPECTIVELY WITH A LUMENIS LIGHTSHEER DESIRE LASER, XC HANDPIECE. IT WAS FURTHER REPORTED THAT THE PATIENT STATED THE TREATMENT WAS PAINFUL WHILE TREATING THE BIKINI AREA. IT WAS NOTED THAT THE PHYSICIAN LOWERED THE TREATMENT SETTINGS MORE THAN NORMAL AND THE PATIENT STILL FELT UNCOMFORTABLE. ADDITIONALLY, THE USER FACILITY STATED THAT THE XC HANDPIECE HAS AN INTERNAL SPOT ON THE OUTPUT DIODE WINDOW. NO REPORT OF SERIOUS INJURY OR MEDICAL INTERVENTION TO PRECLUDE PERMANENT IMPAIRMENT WAS RECEIVED.

    Description of Event or Problem · 1

    A USER FACILITY REPORTED THAT ONE (1) PATIENT HAD HAIR REMOVAL TREATMENT ON THE UPPER LIP, UNDER ARMS, LOWER LEGS, AND BIKINI AREA WITH A LUMENIS LIGHTSHEER DESIRE LASER, XC HANDPIECE. IT WAS FURTHER REPORTED THAT THE PATIENT STATED THE TREATMENT WAS PAINFUL WHILE TREATING THE BIKINI AREA. IT WAS NOTED THAT THE PHYSICIAN LOWERED THE TREATMENT SETTINGS THAN NORMAL AND THE PATIENT STILL FELT UNCOMFORTABLE. ADDITIONALLY, THE USER FACILITY STATED THAT THE XC HANDPIECE HAS AN INTERNAL SPOT ON THE OUTPUT WINDOW. NO REPORT OF SERIOUS INJURY OR MEDICAL INTERVENTION TO PRECLUDE PERMANENT IMPAIRMENT WAS RECEIVED OTHER THAN THE INITIAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    464538 LIGHTSHEER DESIRE SOLID STATE AESTHETIC LASER DELIVERY DEVICE GEX LUMENIS, LTD. LIGHTSHEER DESIRE

    Patients

    Seq Age Sex Outcome Treatment
    1 Other