BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LUMENIS ONE

    MDR report key: 830840 · Received March 16, 2007

    Report

    Report Number
    2914019-2005-00068
    Event Type
    Injury
    Date Received
    March 16, 2007
    Date of Event
    April 1, 2005
    Report Date
    March 16, 2007
    Manufacturer
    LUMENIS LTD
    Product Code
    GEX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PER LUMENIS SERVICE, THE LUMENIS ONE DEVICE WAS WITHIN SPECIFICATION AND ALL OUTPUTS OF THE LIGHTSHEER HEAD WERE ACCURATE. THE CUSTOMER ENGINEER WAS NOT ABLE TO DUPLICATE ANY PROBLEMS WITH THE DEVICE. LIMITED DETAILS WERE PROVIDED FOR BOTH PTS. BASED ON THE AVAILABLE DETAILS, IT APPEARED TO LUMENIS THAT THERE WERE NO PROBLEMS WITH PT 1'S IPL TREATMENT, HOWEVER, CUSTOMER PROVIDED CONFLICTING REPORTS. LUMENIS REQUESTED ADDITIONAL DETAILS, WHICH WERE NOT PROVIDED. IT IS DIFFICULT TO DETERMINE THE ROOT CAUSE OF THE BURNS WITHOUT FURTHER COOPERATION FROM THE CUSTOMER WITH REGARDS TO THE INCIDENT AND TREATMENT DETAILS. ALTHOUGH THERE WAS NO INDICATION OF A POSSIBLE DEVICE PROBLEM DURING THE SERVICE CALLS RELATED TO THIS REPORTED INCIDENT, A FEW MONTHS LATER SERVICE MADE A DECISION TO REPLACE THE UNIT AFTER SEVERAL INCIDENTS OF ERROR CODES THAT COULD NOT BE RESOLVED. NO ADDITIONAL PT INJURIES WERE REPORTED DURING THE ONGOING EVALUATION PERIOD. IN THE ORIGINAL ANALYSIS, THIS INCIDENT WAS DETERMINED BY LUMENIS NOT TO BE MDR REPORTABLE. THIS INCIDENT WAS LATER RECLASSIFIED BY LUMENIS AS MDR REPORTABLE AS A RESULT OF AN INTERNAL AUDIT AND THE FDA LETTER DATED 07/25/06.

    Description of Event or Problem · 1

    PER CUSTOMER, TWO PATIENTS UNDERWENT HAIR REMOVAL TREATMENT WITH THE LIGHTSHEER HEAD OF THE LUMENIS ONE; PATIENT 1 ALSO HAD IPL TREATMENT. PER CUSTOMER, THERE WAS NO EVIDENCE OF BLISTERING AT THE TIME OF THE TREATMENTS. PER THE PHYSICIAN, PT 1 SUSTAINED A SECOND DEGREE BURN, PARTIAL THICKNESS, TO THE LOWER EXTREMITIES. THE PT HAD A NORMAL PERIFOLLICULAR RESPONSE FOLLOWING HAIR REMOVAL TREATMENT AND NO EPIDERMAL DAMAGE WAS EVIDENT UNTIL ABOUT 3-4 DAYS AFTER TREATMENT WHEN THERE WAS BLISTERING, SCABBING AND SLOUGHING. PER THE PHYSICIAN, HYPERIPIGMENTATION IS LIKELY, TREATED WITH HYDROQUINONE (PRESCRIPTION) AND GLYCOLIC WASHES. LIMITED DETAILS WERE PROVIDED TO LUMENIS REGARDING PT 2. BOTH PATIENTS IMPROVING PER CUSTOMER.

    Description of Event or Problem · 2

    PER CUSTOMER, TWO PATIENTS UNDERWENT HAIR REMOVAL TREATMENT WITH THE LIGHTSHEER HEAD OF THE LUMENIS ONE; PATIENT 1 ALSO HAD IPL TREATMENT. PER CUSTOMER, THERE WAS NO EVIDENCE OF BLISTERING AT THE TIME OF THE TREATMENTS. PER THE PHYSICIAN, PT 1 SUSTAINED A SECOND DEGREE BURN, PARTIAL THICKNESS, TO THE LOWER EXTREMITIES. THE PT HAD A NORMAL PERIFOLLICULAR RESPONSE FOLLOWING HAIR REMOVAL TREATMENT AND NO EPIDERMAL DAMAGE WAS EVIDENT UNTIL ABOUT 3-4 DAYS AFTER TREATMENT WHEN THERE WAS BLISTERING, SCABBING AND SLOUGHING. PER THE PHYSICIAN, HYPERIPIGMENTATION IS LIKELY, TREATED WITH HYDROQUINONE (PRESCRIPTION) AND GLYCOLIC WASHES. LIMITED DETAILS WERE PROVIDED TO LUMENIS REGARDING PT 2. BOTH PATIENTS IMPROVING PER CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LUMENIS ONE AESTHETIC LASER GEX LUMENIS LTD * *

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention NONE REPORTED
    2 YR Required Intervention