MAUDE Adverse Event Report: LUMENIS LTD. LIGHTSHEER DESIRE; 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)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Lumenis investigated the reported event by contacting the user facility directly.Six (6) attempts have been made by three (3) emails and three (3) calls to obtain; patient treatment settings, patient information, patient photos which were partly provided by the user facility.No information was received by the user facility.A lumenis service engineer analyzed the device and checked the reported issue of tip getting hot and might have burned a patient.He found coolant to be empty and refilled coolant.Checked energy levels and temperature on the system and found everything to be according to manufacturer specifications.Calibrated the xc hp and completed all checks iaw lightsheer desire service manual per lumenis standards.The system was 100% operational and ready for customer use.The coolant level is not related to the alleged burning as the epi temp can rise up to 7°c and if it exceeds this tempurature the device stops from working with an error message appearing on screen (no errors were reported).No incident forms were sent to lumenis by the user facility, therefore a clinical evaluation wasn't done.While the information received to date does not confirm that a serious injury nor a malfunction occurred, because of the lack of information regarding the injury leaving a permanent impairment, the company is reporting the event in an 'abundance of caution'.Based on the information provided a root cause cannot be determined at this time.The most probable cause of the reported event is user error, a failure on the part of the device operator to follow instructions/warnings described in the device 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 service engineer reported that one (1) patient sustained a burn of unknown severity to an unknown area following treatment with a lumenis lightsheer desire laser.No report of serious injury or medical intervention has been received except for the initial report from the user facility.The facility reported on small hp which needs to be calibrated.Patients are saying that the treatments are painful by the tip is getting hot.

• Brand Name: LIGHTSHEER DESIRE
• 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: 8733559
• Report Number: 3004135191-2019-00073
• Device Sequence Number: 2374807
• Product Code: GEX
• UDI-Device Identifier: 07290109140384
• UDI-Public: 07290109140384
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K170179
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/26/2019

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: 05/29/2019
• Initial Report FDA Received Date: 06/26/2019
• 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