MAUDE Adverse Event Report: LUMENIS LTD LIGHTSHEER DUET HS/ET; POWERED LASER SURGICAL INSTRUMENT

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	08/04/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Lumenis received an adverse event report on a patient who sustained burn following treatment by handpiece et of the lightsheer duet device.Lumenis investigated the reported event by contacting the user facility via regional cru representative.Attempts by emails and phone calls have been made to obtain; patient treatment settings, patient information, patient photo.An examination of the subject device was performed by lumenis service engineer (ce) who visited site shortly after an event.During testing (ce) did not find any faulty functionalities on the device.After testing (ce) returned the handpiece to the clinic in proper working condition.Device malfunction is not the suspected cause of the adverse event.The system was installed on february 24, 2011 and last pm was done on july 5, 2021.Lumenis could not evaluate the rate of injury because the customer refused to disclose any information of the injury, but informed that it happened in vio (bikini) area.Due to lack of information (no incident form received) lumenis is reporting the 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 a patient who sustained burn following treatment by handpiece et of the lightsheer duet device.

• Brand Name: LIGHTSHEER DUET HS/ET
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): LUMENIS LTD; 6 hakidma street; po box 240; yokneam, isr 20692 04; IS 2069204
• MDR Report Key: 12369650
• Report Number: 3004135191-2021-00059
• Device Sequence Number: 17127403
• Product Code: GEX
• UDI-Device Identifier: 07290109143057
• UDI-Public: 07290109143057
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Administrator/Supervisor
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date (Section B): 08/24/2021

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 HS/ET
• Device Catalogue Number: GASB00000
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/04/2021
• Initial Report FDA Received Date: 08/26/2021
• 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