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

Model Number	LIGHTSHEER DUET ET/HS
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
Clarion reported to lumenis on the adverse event.Multiple attempts were made by phone and emails to obtain; patient treatment settings, patient information, patient photos.No information was sent by the user facility.A lumenis service engineer inspected system and found that the device was well functioning.No malfunction was observed by the service engineer.He topped up coolant reservoir.Dusted and vacuumed inside of system (including all computer boards).Inspected and cleaned (if necessary) all optics.- ok.Verified vacuum pressure of hs handpiece.According to spec.Verified all power supplies and voltages.- ok verified heat exchanger calibration / current verification.In spec.Verified epi tip temp calibration.In spec.Verified epi temp current.In spec.Verified delta t temp calibration for hs hand piece.In spec.Verified delta t temp calibration for et hand piece.In spec.Verified energy calibration on hs handpiece.+- 10%.In spec.Verified energy calibration on et handpiece.+- 10%.In spec.Verified all safety circuits - ok verified full functionality of system.- ok verified energy output powers of both handpieces were within manufacturer specifications.Clarion attempted to receive the incident forms of the patient without a reply from the user facility.Thus, no clinical evaluation was done.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 to the fda in an 'abundance of caution'.The root cause of the injury in not clear as no incident forms were sent.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 to clarion on one (1) patient who sustained a burn of unknown severity to an unknown area following treatment with lightsheer duet hs/et laser.No report of serious injury or medical intervention has been received except for the initial report from clarion.

• Brand Name: LIGHTSHEER DUET HS/ET
• Common Device Name: SOLID STATE AESTHETIC LASER DELIVERY DEVICE
• Manufacturer (Section D): LUMENIS LTD.; 6 hakidma street; po box 240; yokneam, 20692 ; IS 20692
• MDR Report Key: 9211937
• Report Number: 3004135191-2019-00122
• Device Sequence Number: 18908485
• 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: foreign,user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/20/2019

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 DUET ET/HS
• Device Catalogue Number: GASB00000
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/23/2019
• Initial Report FDA Received Date: 10/20/2019
• 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