MAUDE Adverse Event Report: LUMENIS LTD. LIGHTSHEER DUET; SOLID STATE AESTHETIC LASER DELIVERY DEVICE

Model Number	LIGHTSHEER
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Burn(s) (1757)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Lumenis investigated the reported event by contacting (b)(6).Several attempts have been made to obtain; patient treatment settings, patient information, patient photos by incident forms.Lumenis hasn't received incident forms of the alleged injury.This reported adverse event was initially reported to lumenis on (b)(6) 2020.Reviewing the past complaints from this facility no safety complaints related to this particular adverse event were reported.Therefore, this case is new to lumenis.In the reported complaint there was no allegation of a device malfunction from the emails sent to lumenis by (b)(6) or their attorney.In the past 2 years, lumenis has been servicing the device.The device was serviced with a pm on 09/05/19, 8/21/18 and 09/05/17 also serviced with a cm on 08/29/19, 10/19/18 and 11/28/217.Lumenis sent the attorney all relevant information on service and maintenance records for the lighsheer device from the date of purchase.The subject device was installed on (b)(6) 2010.While the information received to date does not confirm that a serious injury nor malfunction had occurred, because of the lack of information lumenis 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
Lumenis received an initial report involving a lawsuit against (b)(6) following treatment with a refurbished lightsheer duet.The report was on an alleged injury to a patient.No information on the severity or date of the event was received.

• Brand Name: LIGHTSHEER DUET
• 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: 9837431
• Report Number: 3004135191-2020-00030
• Device Sequence Number: 3037281
• Product Code: GEX
• UDI-Device Identifier: 07290109140483
• UDI-Public: 7290109140483
• Combination Product (Y/N): N
• 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: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 03/16/2020

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
• Device Catalogue Number: RGASB0000
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/18/2020
• Initial Report FDA Received Date: 03/16/2020
• 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