MAUDE Adverse Event Report: LUMENIS, LTD. LIGHTSHEER DUET HS/ET; SOLID STATE AESTHETIC LASER DELIVERY DEVICE

Model Number	LIGHTSHEER DUET HS/ET
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	03/13/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Lumenis investigated the reported event by contacting the foreign facility.Attempts have been made.Patient treatment settings, patient information, patient photos, sun exposure and incident form were not provided.Clarion's service technician inspected the system and concluded that: " opened the backside of the device.Checked the coolant level.It was ok but i still added some more.Checked the energy output of the et hp which is the hp the customer had an issue with a patient.They all were within the accepted ranges but closer to the high end.Therefore, i re-calibrated hp.After the calibration, i performed the energy check.All values were within range.However, sometimes while doing et calibration on the device before the device allows us to use it.I encountered errors 134, 83, 81.But on the other hand, diode temp of et, epi temp are in the accepted ranges.I restarted the device a few times.I encountered this issue, i would say one out of five times.Probably a replacement for the hp would be required.I would need to check with the lab regarding this issue.Moving to the hs hp, i also performed calibration on it.The headroom for this hp are low but energies are still in range".The service technician concluded that all values are within the accepted ranges.Malfunction is not the suspected cause of the reported event.No incident forms were sent to lumenis, thus clinical evaluation wasn't performed.While the information received to date does not confirm that a serious injury occurred nor a malfunction, because of the lack of information regarding the injury leaving a permanent impairment, the company is reporting the event in an abundance of caution.Should additional information become available, the complaint record will be updated accordingly and a follow-up medwatch report will be submitted.Lumenis is forwarding the information of this event to clarion.Clarion decided to report this complaint to (b)(6) health authorities in an abundance of caution.
Event or Problem Description
A foreign facility reported that one (1) patient sustained a burn of unknown severity following treatment with lightsheer duet laser.

• Brand Name: LIGHTSHEER DUET HS/ET
• Common Device Name: SOLID STATE AESTHETIC LASER DELIVERY DEVICE
• Manufacturer (Section D): LUMENIS, LTD.; 6 hakidma st; po box 240; yokneam industrial park, 20692 ; IS 20692
• MDR Report Key: 9932139
• Report Number: 3004135191-2020-00035
• Device Sequence Number: 3752020
• Product Code: GEX
• UDI-Device Identifier: 07290109140483
• UDI-Public: 7290109140483
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K170179
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/07/2020

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 DUET HS/ET
• Device Catalogue Number: GASB00000
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/13/2020
• Initial Report FDA Received Date: 04/07/2020
• 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