MAUDE Adverse Event Report: LUMENIS BE LTD. LIGHTSHEER DUET; POWERED LASER SURGICAL INSTRUMENT, PRODUCT CODE: GEX

Model Number	LIGHTSHEER DUET
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Missing Information (4053)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	11/16/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Lumenis investigated the reported event by contacting the user facility directly.Attempts by emails and phone calls have been made to obtain, patient treatment settings, patient information, patient photo.The customer reported that a couple of patients are having burns since they didn't provide not even one incident form, we'll treat this adverse event in one single complaint.The customer is billable and since they did not initiated testing of this device and didn't paid for that, this device was not tested.Nevertheless, there is no allegation and no indication of malfunction.Clinical evaluation wasn't performed, because the customer did not send neither incident form nor photos to lumenis.Therefore, it's impossible to confirm or exclude user error as well as determine severity of the injury.Moreover, since no technical information was provided by the customer, it's impossible to evaluate technical status of the device.Since no essential information was received within period which is determined for reportability, lumenis is reporting this event to the fda in an 'abundance of caution'.Should additional significant information become available, the complaint record will be updated accordingly and a follow-up medwatch report will be submitted.
Event or Problem Description
Lumenis received an adverse event report on a patients who sustained injury following treatment by ls duet device.

• Brand Name: LIGHTSHEER DUET
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT, PRODUCT CODE: GEX
• Manufacturer (Section D): LUMENIS BE LTD.; 9 hakidma st.; p.o.b 426; yokneam illit, israel 20692 36; IS 2069236
• Manufacturer (Section G): LUMENIS BE LTD.; 9 hakidma st.; p.o.b 426; yokneam illit, israel 20692 36; IS 2069236
• Manufacturer Contact: roman vernik ; 9 hakidma st.; p.o.b 426; yokneam illit, israel 20692-36 ; IS 2069236
• MDR Report Key: 18324097
• Report Number: 3021349626-2023-00022
• Device Sequence Number: 7358851
• Product Code: GEX
• UDI-Device Identifier: 07290109143057
• UDI-Public: 07290109143057
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K170179
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/14/2023

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
• Device Catalogue Number: GASB00000
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/16/2023
• Initial Report FDA Received Date: 12/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/11/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Prefer Not To Disclose
• Patient Ethnicity: Non Hispanic