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

Model Number	LIGHTSHEER QUATTRO
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	06/22/2021
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.An examination of the subject device was performed by lumenis service engineer after verifying all system functions including coolant level check that was found at low level, refilled reservoir.Energy readings registered high, more than 20%.Performed power meter calibration.Energy readings within spec.After recalibration.Ce wasn't able to duplicate the reported problem.No device malfunction was observed.The system was operational and was ready for use.Device malfunction wasn't the suspected cause of the adverse event.Probably this was a user error, the user didn't perform a calibration on time.According to user manual, calibration is required when a new handpiece is authorized to operate with the system, and after every cycle of 30,000 pulses.This system was installed on july, 28 2020, no such issue was found according to the system history.Pm was not performed yet due to new system, based on service manual preventive maintenance visit should be conducted once a year.Clinical evaluation wasn't performed, since no incident form or photos were sent to lumenis.Lumenis tried several time to achieve more information directly from the customer, but without success.According to the information received there was no device malfunction.Probably this was a user error, the user didn't perform a calibration on time.Based on 1010482 _rev h- quattro family risk analysis matrix - mis-calibration ( par.#2.1.3 and #2.1.3.1), the risk is within the acceptable risk.No clinical evaluation was performed due to lack of information, although lumenis tried to achieve more information from the customer.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 lightsheer quattro device.

• Brand Name: LIGHTSHEER QUATTRO
• Common Device Name: SOLID STATE AESTHETIC LASER DELIVERY DEVICE
• Manufacturer (Section D): LUMENIS LTD.; 6 hakidma street; po box 240; yokneam, isr 20692 ; IS 20692
• MDR Report Key: 12201318
• Report Number: 3004135191-2021-00047
• Device Sequence Number: 19927907
• Product Code: GEX
• UDI-Device Identifier: 07290109144658
• UDI-Public: 07290109144658
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 07/21/2021

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 QUATTRO
• Device Catalogue Number: GA-1140000
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/22/2021
• Initial Report FDA Received Date: 07/21/2021
• 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