BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESURFX

    MDR report key: 6343781 · Received February 20, 2017

    Report

    Report Number
    3004135191-2017-00018
    Event Type
    Malfunction
    Date Received
    February 20, 2017
    Report Date
    July 23, 2018
    Manufacturer
    LUMENIS, LTD
    Product Code
    ONG
    PMA / PMN Number
    K130028
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ***ADDITIONAL INFORMATION (B)(6) 2018. A REVIEW OF DEVICE LABELING UM-1024721 STATES THE FOLLOWING: WARNING - PERFORM TEST SPOTS ON PATIENTS AND ASSESS SKIN RESPONSE BEFORE PERFORMING A FULL TREATMENT. SIDE EFFECTS MAY NOT DEVELOP UNTIL SEVERAL DAYS FOLLOWING EXPOSURE. FOR SKIN TYPE V, WAIT AT LEAST 48-72 HOURS AFTER TEST SPOTS TO OBSERVE TISSUE REACTION. ALWAYS ALLOW ADEQUATE TIME BETWEEN TEST SPOT AND ACTUAL TREATMENT. SUBJECT DEVICE WAS RECEIVED AT LUMENIS LTD. AND BASED ON PERFORMED INVESTIGATION A LUMENIS QUALITY ENGINEER CONCLUDED BY STATING, "SYSTEM PASSED FULL TESTING SESSION IN R.H. - NO MALFUNCTION\DEVIATIONS WERE IDENTIFIED". BASED ON THE INFORMATION ABOVE, LUMENIS IS WITHDRAWING THE MALFUNCTION CLAIM, HAS CHANGED THE DEVICE, METHOD, RESULT, CONCLUSION CODES IN BLOCK H6 OF THIS REPORT AND CLOSING THE COMPLAINT.

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE SUBJECT DEVICE SERVICE RECORDS FOUND THE SYSTEM HAD RECENTLY BEEN SERVICED BY A LUMENIS CERTIFIED TECHNICIAN WITHIN (1) ONE MONTH OF THE EVENT DATE. UPON COMPLETION OF THE SERVICE VISIT, THE SYSTEM WAS TESTED AND FOUND TO OPERATE WITHIN SPECIFICATIONS AND SAFE TO USE. A LUMENIS CLINICAL MANAGER REVIEWED THE PHOTOGRAPHS OF THE POST-TREATMENT PATIENT, AND CONCLUDED "EXCESS ENERGY RESULTED IN PIN-POINT PETECHIAE. A TEST SPOT SHOULD ALWAYS BE PERFORMED BEFORE TREATMENTS, ESPECIALLY FOLLOWING SERVICING A SYSTEM. ADEQUATE TIME SHOULD BE GIVEN BETWEEN TEST PATCHES AND ACTUAL TREATMENT IN ORDER TO REVIEW THE SKIN'S RESPONSE. THE CONDITION IS TRANSIENT AND SHOULD RESOLVE WITHIN ~2 WEEKS. SUN AVOIDANCE IS ADVISED AND SUN SCREEN SHOULD BE APPLIED DAILY." ABSENT PATIENT DATA AND TREATMENT SETTINGS, THE CLINICAL DIRECTOR WAS UNABLE TO EVALUATE THE APPROPRIATENESS OF THE SETTINGS. WHILE THE INFORMATION RECEIVED TO DATE DOES NOT SUGGEST THAT A MALFUNCTION OCCURRED, BECAUSE OF THE LACK OF INFORMATION THE COMPANY IS REPORTING THE EVENT IN AN ABUNDANCE OF CAUTION. ONCE ADDITIONAL INFORMATION BECOMES AVAILABLE, THE COMPLAINT RECORD WILL BE UPDATED ACCORDINGLY, AND A FOLLOW UP MEDWATCH REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A FOREIGN USER FACILITY REPORTS THAT (3) THREE PATIENTS GOT PETECHIAE IMMEDIATELY FOLLOWING A RESURFX TREATMENT. NO REPORT OF SERIOUS INJURY OR MEDICAL INTERVENTION TO PRECLUDE PERMANENT IMPAIRMENT WERE RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125970 RESURFX RESURFX SYSTEM ONG LUMENIS, LTD RESURFX

    Patients

    Seq Age Sex Outcome Treatment
    1