BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MIRADRY SYSTEM

    MDR report key: 5051533 · Received September 2, 2015

    Report

    Report Number
    3008082710-2015-00023
    Event Type
    Malfunction
    Date Received
    September 2, 2015
    Date of Event
    January 22, 2015
    Report Date
    February 24, 2015
    Manufacturer
    MIRAMAR LABS, INC.
    Product Code
    OUB
    PMA / PMN Number
    K131162
    Removal / Correction Number
    Z-0234-2016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF LOT HISTORY RECORDS FOR THE INVOLVED DEVICES CONFIRMED MANUFACTURING STEPS AND PROCESSES WERE MET AND FOLLOWED. THERE HAVE BEEN NO ISSUES WITH ANY STERILE DISPOSABLE MANUFACTURING LOTS PRODUCED TO DATE. PRODUCT MET SPECIFICATIONS PRIOR TO SHIPMENT. SIMILAR REPORTS WERE SEEN AT THIS CLINIC. INVESTIGATION IS STILL ONGOING AS TO ROOT CAUSE. DEVICE MALFUNCTION WITH POTENTIAL FOR SERIOUS INJURY IS NOT RULED OUT SO THIS REPORT IS BEING FILED. THIS EVENT REPORTED IS NOT A SERIOUS INJURY. MISSING INFORMATION WAS NOT AVAILABLE AT THE TIME OF THIS REPORT. EVALUATION SUMMARY DATA FROM SYSTEM LOGS WAS COLLECTED AND ANALYZED. POWER AND VACUUM LOOKED STABLE OVER TIME. HOWEVER, PEAK TEMPERATURES AS MEASURED ON TEMPERATURE SENSORS SHOWED INCREASE. HANDPIECE WAS RETURNED ON (B)(6) 2015 TO INVESTIGATE POSSIBLE REASONS FOR LESS EFFICIENT COOLING. SUBSEQUENTLY IT WAS ALSO DISCOVERED THAT CLINIC WAS USING A DIFFERENT GEL THAN RECOMMENDED FOR SKIN LUBRICATION. BOTH AVENUES ARE STILL BEING EXPLORED. INVESTIGATION IS STILL OPEN AND A FOLLOW-UP REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    REVIEW OF LOT HISTORY RECORDS FOR THE INVOLVED DEVICES CONFIRMED MANUFACTURING STEPS AND PROCESSES WERE MET AND FOLLOWED. THERE HAVE BEEN NO ISSUES WITH ANY STERILE DISPOSABLE MANUFACTURING LOTS PRODUCED TO DATE. PRODUCT MET SPECIFICATIONS PRIOR TO SHIPMENT. SIMILAR REPORTS WERE SEEN AT THIS CLINIC. INVESTIGATION IS STILL ONGOING AS TO ROOT CAUSE. DEVICE MALFUNCTION WITH POTENTIAL FOR SERIOUS INJURY IS NOT RULED OUT SO THIS REPORT IS BEING FILED. THIS EVENT REPORTED IS NOT A SERIOUS INJURY. MISSING INFORMATION WAS NOT AVAILABLE AT THE TIME OF THIS REPORT. EVALUATION SUMMARY: DATA FROM SYSTEM LOGS WAS COLLECTED AND ANALYZED. POWER AND VACUUM LOOKED STABLE OVER TIME. HOWEVER, PEAK TEMPERATURES AS MEASURED ON TEMPERATURE SENSORS SHOWED INCREASE. HANDPIECE WAS RETURNED ON MARCH 6TH, 2015 TO INVESTIGATE POSSIBLE REASONS FOR LESS EFFICIENT COOLING. SUBSEQUENTLY IT WAS ALSO DISCOVERED THAT CLINIC WAS USING A DIFFERENT GEL THAN RECOMMENDED FOR SKIN LUBRICATION. BOTH AVENUES ARE STILL BEING EXPLORED. INVESTIGATION IS STILL OPEN AND A FOLLOW-UP REPORT WILL BE FILED. INVESTIGATION HAS CONCLUDED, AND DETERMINED THAT THE USER'S CHOICE OF AN UNVALIDATED SUBSTANCE FOR SKIN LUBRICATION INTERFERED WITH THE DEVICE'S COOLING MECHANISM. NO SERIOUS INJURY OCCURRED (REVIEWED BY INDEPENDENT MEDICAL PERSONNEL), AND INVESTIGATION HAS DETERMINED THAT THIS USER ERROR WOULD NOT RESULT IN A SERIOUS INJURY. THE USER MANUAL HAS BEEN UPDATED.

    Description of Event or Problem · 1

    PHYSICIAN NOTED ONE SMALL (5MM OR LESS) BLISTER ON RIGHT UNDERARM IMMEDIATELY POST-TREATMENT. APPLIED CORTICOSTEROID/ANTIBIOTIC OINTMENT. THE PATIENT DID NOT COME BACK TO THE CLINIC. PHYSICIAN WAS NOT GOING TO FOLLOW THE PATIENT ANY LONGER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    583034 MIRADRY SYSTEM MICROWAVE DERMATOLOGIC SYSTEM OUB MIRAMAR LABS, INC. MD4000-HP 12H0706

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Required Intervention