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

Model Number	LIGHTSHEER DUET HS/ET
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Burn(s) (1757); Insufficient Information (4580)
Date of Event	04/25/2023
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 device gasb00000:(b)(6) was installed in the facility on (b)(6)2013 and the most recent pm was done on (b)(6)2022.Service engineer tested the device on 05/03/2023 and advised: "the customer reported that the system is burning patients and vacuum is too low on hs handpiece.Began by replacing the water filter and vacuum filters, performed handpiece calibration.Cleaned all internal parts from dust, system is running better post service.Finally, performed an energy output test: all passed within manufacture specifications".Device malfunction wasn't the suspected cause of the adverse event.Lumenis representative called and spoke with the customer who was very upset that her service contract insurance was canceled.She didn't want to pay $2200 to have a filter replaced.The customer was advised to call the service team and work with them.Lumenis strongly recommends to perform timely maintenance of their devices.Initiative and payment for technical service to keep the device in proper working condition lies on customer's responsibility regardless to the type of service contract.According to the service manual: " the system monitors the vacuum pressure of the hs handpiece.Vacuum level is set to a user selected pressure value.After pressing the trigger, the system allows four seconds to reach the user selected pressure with a tolerance of ± 2 inches hg.If the desired pressure is not reached within this time, the system will not allow the user to fire the laser.The error message is displayed.This error message can be cleared by releasing and pressing trigger".Therefore, it's impossible to operate the system having low vacuum level.According to the risk file: rd-1084050_n lightsheer duet risk management matrix, par.1.1.7.2 the risk of wrong vacuum indication due to filter clogging, has been evaluated and lies within acceptable limits.Risk control measures: software monitors the tip vacuum on the hs handpiece and does not allow lasing if threshold is not reached.Disposable tip with vacuum filter to void clogging air filters are added to disposable tip on the hs handpiece to collect debris and reduce particles from entering into the systems internal components.User manual provides user guidelines on disposable tip usage.According to the information received there is no malfunction found on the system.Clinical evaluation wasn't performed, because the customer did not sent neither incident form nor photos to lumenis.Due to lack of clinical information it's impossible to confirm or exclude user error as well as determine severity of the injury.Therefore, lumenis is reporting this event 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 eight (8) patients who sustained burn following treatment by lightsheer duet device.Since customer reported on 8 injured patients, but did not send us even one incident form, this case will be treated in one single complaint.

• Brand Name: LIGHTSHEER DUET HS/ET
• 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: 16973306
• Report Number: 3021349626-2023-00009
• Device Sequence Number: 6724130
• Product Code: GEX
• UDI-Device Identifier: 07290109141596
• UDI-Public: 07290109141596
• Combination Product (Y/N): N
• 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 Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/22/2023

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: Health Professional
• Device Model Number: LIGHTSHEER DUET HS/ET
• Device Catalogue Number: GASB00000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/25/2023
• Initial Report FDA Received Date: 05/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/11/2013
• 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: Reuse
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: MW5113591
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Prefer Not To Disclose
• Patient Ethnicity: Non Hispanic