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	Unexpected Therapeutic Results (1631)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	05/13/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Lumenis investigated the reported event by contacting the user facility by three (3) emails; patient treatment settings, patient information, patient photos, which were not provided by the user facility.No clinical evaluation was done by lumenis as no incident forms were sent by the user facility.Lumenis service engineer visited the site and noted that the customer reported that ultimately only slight skin irritations occurred without late effects in a patient.He concluded that system-related maintenance carried out according to lumenis specifications, including cleaning the system; cooling hoses checked malfunction is not the suspected cause of the event.While the information received to date does not confirm that a serious injury occurred, due to the lack of information regarding the injury leaving a permanent impairment, the company is reporting the event in an 'abundance of caution'.Should significant 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 facility reported that during a procedure with lightsheer duet a patient was burnt.The facility reported on cooling problems.

• Brand Name: LIGHTSHEER DUET HS/ET
• Common Device Name: SOLID STATE AESTHETIC LASER DELIVERY DEVICE
• Manufacturer (Section D): LUMENIS, LTD.; 6 hakidma st; po box 240; yokneam industrial park, 20692 ; IS 20692
• MDR Report Key: 10127939
• Report Number: 3004135191-2020-00044
• Device Sequence Number: 11583806
• Product Code: GEX
• UDI-Device Identifier: 07290109140483
• UDI-Public: 7290109140483
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/08/2020

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: 05/13/2020
• Initial Report FDA Received Date: 06/08/2020
• 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