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

Model Number	LIGHTSHEER
Medical Device Problem Code	Unexpected Therapeutic Results (1631)
Health Effect - Clinical Code	Burn(s) (1757)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Lumenis investigated the reported event by contacting the user facility directly.Three (3) attempts by emails and phone calls have been made to obtain; patient treatment settings, patient information, patient photos.No information has been provided by the user facility.An examination of the subject device by a lumenis service engineer evaluated the device after verifying all system functions including calibration and energy output verification, the device operated well within manufacture specifications.He verified energy output on both 805 and 1060 handpieces.Recalibrated the internal power meter and verified cooling tip temperature to measure 15 deg celsius.Also, calibrated epi tip to measure slightly lower to facilitate comfort 14.4 deg celsius.The coolant was to the appropriate level.No reported error codes were seen by the engineer.The system was safe to use.Therefore, no device malfunction was reported or observed.Device malfunction is not the suspected cause of the reported event.While the information received to date does not confirm that a serious injury nor malfunction had occurred, due to the lack of information the company 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
A user facility reported that one (1) patient sustained a burn of unknown severity to an unknown area following treatment with a lumenis lightsheer infinity laser.No report of serious injury or medical intervention has been received except for the initial report from the user facility.They mentioned they needed to calibrate the system a few times during procedure.On (b)(6) a patient reported on marks and hyperpigmentation and uncomfortable in the treated area.No reports of broken skin, bleeding, blisters, and no reported error codes at the time of the call.

• Brand Name: LIGHTSHEER INFINITY SYSTEM
• 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: 9179704
• Report Number: 3004135191-2019-00116
• Device Sequence Number: 2568629
• Product Code: GEX
• UDI-Device Identifier: 07290109140438
• UDI-Public: 7290109140438
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Nurse Practitioner
• Type of Report: Initial
• Report Date (Section B): 10/11/2019

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: GA-1001804
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/13/2019
• Initial Report FDA Received Date: 10/11/2019
• 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