MAUDE Adverse Event Report: LUMENIS LTD. LIGHTSHEER DESIRE LASER SYSTEM; INTENSE PULSE LIGHT DELIVERY DEVICE

Model Number	LIGHTSHEER DESIRE
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	04/04/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Lumenis investigated the reported event by contacting the foreign user facility.Attempts have been made by phone to obtain; patient treatment settings, patient information, patient photos, which were provided.A lumenis service engineer evaluated the device after the reported incident.He carried out a visual inspection on the system.Found small dark mark on the lens which required some minor abrasion to remove.The customer was reminded of the importance of keeping the handpiece lens clean.Carried energy check into external power meter into an external power meter using et head.All readings were within 10% of expected fluence across range and mode.Also, he checked calibration window glass was okay.Carried out et head calibration and rechecked energy into external power mater.All readings again within 10% of expected fluence, checked chilltip temperature calibration.The chill tip temperature was according to spec.Swapped to hs head.Checked vacuum operation an was according to spec.Carried out energy check into an external power meter.All readings within 10% of expected fluence.Carried out hs head calibration.Rechecked energy into an external power meter.Again all readings were within 10% tolerance.Safety check completed and the system was safe to use.According to user manual um-1080310, rev.E, when performing calibration: "ensure that the handpiece's sapphire tip is clean and dry, ensure that the energy meter's protective window is present and clean.Warning - the internal energy meter window must be clean to ensure accurate calibration.An unclean window will result in higher than indicated fluence, which may cause epidermal damage." thus, it's the user responsibility to make sure the handpiece is clean prior to use.A lumenis healthcare professional and clinical trainer concluded "in regards to the provided patient and treatment-related data (including examination of the incident report form but lacking a patient photograph), assessment of the skin condition and/or skin type may be adequate although most african skin types might be defined as skin types vi and not v.Now, test spot was made at 20j/cm² and 400ms while actual treatment was made with 17j/cm² and 100ms which provide completely different outcome and is far more aggressive than test patch settings.The device was, therefore, subject to user error.As per indication reported in the incident form, the patient sustained a second-degree burn which was not followed up by any medical intervention.The adverse event is hypopigmentation and is likely to lead to permanent impairment.As a result, the hazard severity has been ranked to a level of 6 - moderate." while the information received to date does not confirm that a malfunction had occurred, the injury was defined as 'moderate' and because of the lack of information regarding the chance of permanent impairment, the company is reporting the event.The most probable cause of the reported event acc.To the clinical trainer is a user error, a failure on the part of the device operator to follow instructions described in the user manual.Should additional information become available, the complaint record will be updated accordingly, and a follow-up medwatch report will be submitted.
Event or Problem Description
A foreign user facility reported that one (1) patient sustained a burn to the chin following treatment with a lumenis lightsheer desire laser.Incident forms were sent by the user facility.

• Brand Name: LIGHTSHEER DESIRE LASER SYSTEM
• Common Device Name: INTENSE PULSE LIGHT DELIVERY DEVICE
• Manufacturer (Section D): LUMENIS LTD.; 6 hakidma street; po box 240; yokneam, 20692 ; IS 20692
• MDR Report Key: 8789026
• Report Number: 3004135191-2019-00080
• Device Sequence Number: 11238914
• Product Code: GEX
• UDI-Device Identifier: 07290109140384
• UDI-Public: 07290109140384
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K170179
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Other
• Device Model Number: LIGHTSHEER DESIRE
• Device Catalogue Number: GA-1170000
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/20/2019
• Initial Report FDA Received Date: 07/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 25 YR