BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XEO

    MDR report key: 6382989 · Received March 6, 2017

    Report

    Report Number
    2954354-2017-00001
    Event Type
    Malfunction
    Date Received
    March 6, 2017
    Date of Event
    January 5, 2017
    Report Date
    January 9, 2017
    Manufacturer
    CUTERA, INC
    Product Code
    GEX
    PMA / PMN Number
    K153671
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2017: THE PATIENT RECEIVED AT TITAN XL TREATMENT TO THE LOWER FACE AND NECK THAT RESULTED IN BLISTERS, REDNESS AND CUTANEOUS INDENTIONS. THE TITAN XL IS A DETACHABLE INFRARED HANDPIECE (1100 NM - 1800 NM) THAT PROVIDES TOPICAL HEATING OF THE TISSUE. ON 1/17/2017: THE XEO LASER SYSTEM (XP13789) AND TITAN XL HANDPIECE (TX1836) WERE EVALUATED BY CUTERA FIELD SERVICE. THE TITAN XL(TX1836) HANDPIECE ENERGY OUTPUT AND COOLING WERE VERIFIED TO MEET PERFORMANCE SPECIFICATIONS. THERE WERE NO TITAN XL (TX1836) MALFUNCTIONS OR FAILURES IDENTIFIED BY THE FIELD SERVICE ENGINEER. THE LASER CONSOLE(XP13789) REQUIRED ROUTINE SERVICE UNRELATED TO THE TITAN XL HANDPIECE. ON 1/30/2017: THE TITAN XL HANDPIECE (TX1836) WAS RETURNED TO CUTERA ADDITIONAL INSPECTION AND TESTING BY CUTERA QUALITY ENGINEERING. THE TITAN XL HANDPIECE (TX1836) MEETS PERFORMANCE SPECIFICATIONS. THE QUALITY ENGINEER DID NOT IDENTIFY ANY MALFUNCTIONS OR FAILURES IN THE PERFORMANCE OF TITAN XL (TX1836). THE QUALITY ENGINEER REQUESTED ADDITIONAL TESTING OF THE XEO LASER CONSOLE (XP13789) AFTER REVIEWING THE XEO LASER ERROR LOG THAT WAS OBTAINED BY THE FIELD SERVICE ENGINEER ON 1/17/2017. ON 2/10/2017: CUTERA FIELD SERVICE PERFORMED ADDITIONAL TESTING ON THE XEO LASER CONSOLE (XP13789) AND IDENTIFIED THAT THE SYSTEM SOFTWARE IS NOT IDENTIFYING THE CORRECT MODEL OF THE TITAN HANDPIECE WHEN THE HANDPIECE IS ATTACHED TO THE CONSOLE. THE SOFTWARE IS IDENTIFYING THE TITAN MODEL AS "TITAN S" INSTEAD OF "TITAN XL". THE FIELD SERVICE ENGINEER TESTED A TITAN XL HANDPIECE ON XEO LASER CONSOLE (XP13789) AND VERIFIED THAT THE ENERGY OUTPUT AND COOLING OF THE TITAN XL HANDPIECE ARE WITHIN SPECIFICATIONS EVEN THOUGH THE SHOT LOG AND ERROR LOG IDENTIFY THE "TITAN XL" AS A "TITAN S" MODEL. THE LASER SYSTEM IS PENDING RETURN TO CUTERA FOR FURTHER TESTING BY QA ENGINEERING. ON 4/15/2017: TESTING QA ENGINEER INSPECTION AND TESTING CONCLUSION: NO FUNCTIONAL FAILURE FOUND. THE INTERNAL AND EXTERNAL CONDITION & SOFTWARE VERSION OF THE LASER SHOWED THE SYSTEM WAS NOT MAINTAINED & NOT SERVICED AS RECOMMENDED IN THE XEO LASER INSTRUCTIONS FOR USE. THERE WAS NOT ANY SERVICE PERFORMED BY CUTERA FIELD SERVICE IN THE YEARS 2013, 2014, 2015 & 2016. THERE WAS A LOGGING ERROR IN THE INTERNAL MEMORY BUT THE LOGGING ERROR DID NOT AFFECT THE PERFORMANCE (ENERGY OUTPUT AND COOLING) OF THE HANDPIECE. ENERGY OUTPUT AND COOLING MEASUREMENTS MEET PERFORMANCE SPECIFICATIONS. THE LINEAR BURN PATTERNS ARE CONSISTENT WITH THE 1 CM X 3 CM SPOT SIZE. IN ORDER FOR THE BURN INJURY TO OCCUR IN A LINEAR PATTERN CONSISTENT WITH THE 1 CM X 3 CM SPOT SIZE OF THE OUTPUT SURFACE OF THE WINDOW, THE TREATMENT WINDOW MUCH HAVE BEEN IN A FIXED POSITION RELATIVE TO THE SKIN DURING THE ENERGY DELIVERY. ROOT CAUSE OF BURNS - INTERMITTENT USER ERROR - TREATMENT TECHNIQUE - HOLD THE TREATMENT WINDOW IN A FIXED POSITION RELATIVE TO THE SKIN WHILE MOVING THE HANDPIECE IN SMALL CIRCLES (CARRYING THE SKIN WITH THE TREATMENT WINDOW) DURING THE ENERGY DELIVERY. THE SETTINGS FOR THE MOBILE TREATMENT TECHNIQUE ARE HIGHER THAN THE SETTINGS FOR THE STATIONARY TREATMENT BECAUSE THE ENERGY IN THE MOBILE TECH QUE IS INTENDED TO BE SPREAD OUT OVER A LARGER SURFACE AREA.

    Description of Event or Problem · 1

    (B)(6) 2017: THE PATIENT RECEIVED AT TITAN XL TREATMENT TO THE LOWER FACE AND NECK THAT RESULTED IN BLISTERS, REDNESS AND CUTANEOUS INDENTIONS. THE TITAN XL IS A DETACHABLE INFRARED HANDPIECE (1100 NM - 1800 NM) THAT PROVIDES TOPICAL HEATING OF THE TISSUE. (B)(6) 2017: THE XEO LASER SYSTEM ((B)(4)) AND TITAN XL HANDPIECE ((B)(4)) WERE EVALUATED BY CUTERA FIELD SERVICE. THE TITAN XL ((B)(4)) HANDPIECE ENERGY OUTPUT AND COOLING WERE VERIFIED TO MEET PERFORMANCE SPECIFICATIONS. THERE WERE NO TITAN XL ((B)(4)) MALFUNCTIONS OR FAILURES IDENTIFIED BY THE FIELD SERVICE ENGINEER. THE LASER CONSOLE((B)(4)) REQUIRED ROUTINE SERVICE UNRELATED TO THE TITAN XL HANDPIECE. ON 1/30/2017: THE TITAN XL HANDPIECE ((B)(4)) WAS RETURNED TO CUTERA ADDITIONAL INSPECTION AND TESTING BY CUTERA QUALITY ENGINEERING. THE TITAN XL HANDPIECE ((B)(4)) MEETS PERFORMANCE SPECIFICATIONS. THE QUALITY ENGINEER DID NOT IDENTIFY ANY MALFUNCTIONS OR FAILURES IN THE PERFORMANCE OF TITAN XL ((B)(4)). THE QUALITY ENGINEER REQUESTED ADDITIONAL TESTING OF THE XEO LASER CONSOLE ((B)(4)) AFTER REVIEWING THE XEO LASER ERROR LOG THAT WAS OBTAINED BY THE FIELD SERVICE ENGINEER ON 1/17/2017. ON 2/10/2017: CUTERA FIELD SERVICE PERFORMED ADDITIONAL TESTING ON THE XEO LASER CONSOLE ((B)(4)) AND IDENTIFIED THAT THE SYSTEM SOFTWARE IS NOT IDENTIFYING THE CORRECT MODEL OF THE TITAN HANDPIECE WHEN THE HANDPIECE IS ATTACHED TO THE CONSOLE. THE SOFTWARE IS IDENTIFYING THE TITAN MODEL AS "TITAN S" INSTEAD OF "TITAN XL". THE FIELD SERVICE ENGINEER TESTED A TITAN XL HANDPIECE ON XEO LASER CONSOLE ((B)(4)) AND VERIFIED THAT THE ENERGY OUTPUT AND COOLING OF THE TITAN XL HANDPIECE ARE WITHIN SPECIFICATIONS EVEN THOUGH THE SHOT LOG AND ERROR LOG IDENTIFY THE "TITAN XL" AS A "TITAN S" MODEL. THE LASER SYSTEM IS PENDING RETURN TO CUTERA FOR FURTHER TESTING BY QA ENGINEERING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    163443 XEO 1064 NM ND:YAG LASER GEX CUTERA, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Other