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	08/26/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Lumenis investigated the reported event by contacting the user facility directly.Three (3) attempts have been made by phone to obtain; patient treatment settings, patient information, patient photos.The incident forms were received in the last few days without being analyzed by lumenis.An examination of the subject device by a lumenis technical engineer stated customer had an issue with energy during use.Calibrated energy of hs handpiece and confirmed energy at various settings.Replaced solar detector for preventative reasons and recalibrated once again.Found results of calibration within specifications.Once again, verified calibration at all points in the service manual for both hs and et handpieces.Verified energy was stable with each pulse.Checked all laser parameters.Verified safety, mechanical and interface functions.Verified all system operations.The system was ready for use.While the information received to date does not confirm that a serious injury nor malfunction had occurred, because of the lack of information 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.
Event or Problem Description
A user facility reported that several patients sustained burn of unknown severity to the following treatment with lumenis lightsheer duet laser.No report of serious injury or medical intervention has been received except for the initial report from the user facility.The complaint represents all patients as lumenis received only one incident form.

• 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: 9108326
• Report Number: 3004135191-2019-00109
• Device Sequence Number: 11659702
• Product Code: GEX
• UDI-Device Identifier: 07290109140483
• UDI-Public: 7290109140483
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 09/24/2019

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: Health Professional
• 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: 08/27/2019
• Initial Report FDA Received Date: 09/24/2019
• 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: 47 YR