BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGHTSHEER XC

    MDR report key: 9449541 · Received December 11, 2019

    Report

    Report Number
    3004135191-2019-00142
    Event Type
    Malfunction
    Date Received
    December 11, 2019
    Date of Event
    November 12, 2019
    Report Date
    December 9, 2019
    Manufacturer
    LUMENIS, LTD.
    Product Code
    GEX
    PMA / PMN Number
    K170179
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    LUMENIS INVESTIGATED THE REPORTED EVENT BY CONTACTING THE USER FACILITY DIRECTLY. PATIENT TREATMENT SETTINGS, PATIENT INFORMATION AND INCIDENT FORM HAVE BEEN PROVIDED BY THE USER FACILITY. A LUMENIS HEALTHCARE PROFESSIONAL REVIEWED THE REPORTED EVENT DETAILS STATED " CUSTOMER COMPLAINT THAT THREE PATIENTS HAVE HAD BRUISING POST-TREATMENT WITH THE LIGHT SHEER XC. PT WAS SKIN TYPE III, UNKNOWN AGE FEMALE WITH TREATMENT TO HER UPPER THIGH FOR HAIR REMOVAL. TREATMENT SETTINGS FOR BLACK COARSE HAIR, 20 JOULES 30MS SINGLE PULSE WITH THE 805NM XC(12X12) HANDPIECE WITH THE CHILL TIP ON. A TEST SPOT WAS PREFORMED 15 MINS PRIOR TO TREATMENT. THE PATIENT REPORTS UPPER THIGH BRUISE LASTING APPROX 1-WEEK POST-TREATMENT. LUMENIS SERVICE ENGINEER EVALUATION NOTES THAT THE OUTPUT WAS ELEVATED". THE LUMENIS HEALTHCARE PROFESSIONAL AND CLINICAL TRAINER DETERMINED THE INJURY AS A 'NONE INJURY' (RANKED AS 1). A LUMENIS SERVICE ENGINEER EVALUATED THE SUBJECT DEVICE CONFIRMING THAT THE POWER OF THE DEVICE WAS OUT OF SPECIFICATION. DUE TO THAT REASON, HE REMOVED FROM USE. HE ORDERED NEW CONTROL BOARDS. THE COMPANY IS REPORTING THE EVENT IN AN ABUNDANCE OF CAUTION, LUMENIS HAS OPENED AN INVESTIGATION REGARDING THIS COMPLAINT IN ORDER TO EVALUATE WHETHER THE MALFUNCTION COULD CAUSE A SERIOUS INJURY IF IT WERE TO RECUR, ALTHOUGH IN THIS CASE, THE MALFUNCTION DIDN'T LEAD TO A SERIOUS INJURY. UPON COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLIANT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, THE COMPLAINT RECORD WILL BE UPDATED AND A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    A USER FACILITY REPORTED THAT THREE (3) PATIENTS SUFFER FROM BRUISING AND SWELLING IMMEDIATELY AFTER TREATMENT WITH THE LIGHTSHEER. THIS COMPLAINT IS FOR PATIENT 2 OF 3, INITIALS KK SUFFERS FROM BRUISING ON THE FACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1248812 LIGHTSHEER XC SOLID STATE AESTHETIC LASER DELIVERY DEVICE GEX LUMENIS, LTD. LIGHTSHEER XC

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR