MAUDE Adverse Event Report: LUMENIS BE LIGHTSHEER DESIRE LASER SYSTEM; SOLID STATE AESTHETIC LASER DELIVERY DEVICE

Model Number	LIGHTSHEER DESIRE LASER SYSTEM
Medical Device Problem Codes	Break (1069); Calibration Problem (2890)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	10/18/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Lumenis received an adverse event report on physician and two patients who sustained burns following treatment by lightsheer desire laser system_ga-1170000:(b)(4) device.The customer reported, that device stops after three pulses and physician burned herself and two more people got burned as well.They also reported technical issues: some screws came off from the back panel where the power cord and interlock plug are located.
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.The device ls desire_ga-1170000:(b)(4) was installed on (b)(6) 2017 and the last pm was done on (b)(6) 2021.No technical issues were detected.Service engineer visited facility for testing and evaluation of the device.His findings as following: hs hand piece had a broken protective glass.Ordered a new one and replaced it and calibrated the hand piece.Ran tests and it works properly now.Tightened interlock connection.Machine is now operating properly and is ready for customer use.According to the information received there was device malfunction caused by improper handling.According to gso personnel, broken protective glass does not affect amount of the emitted energy, but both damaged protective glass of the hp, and uncalibrated hp indicates presence of mechanical damage to the hp.Moreover, customer reported, that device stops after three pulses and also reported technical issues: some screws came off from the back panel where the power cord and interlock plug are located.It is not clear why customer decided to use device even after finding all these defects, with no additional testing, but using non-calibrated device caused to delivering of the excessive energy to the patients during treatment.Based on risk file doc no.:1000577_r lightsheer desire family risk analysis and report: 1.Excess energy; 1.1.5 improper parameter settings for treatment; 1.1.5.1 wrong parameters chosen; delivery of the excessive energy can lead to minor skin burn or mistreatment.As one of control measures implemented to reduce this risk is user manual guidance that instructs user to perform test spots prior to treatment intend to be used by licensed professionals.Because customer claimed that, physician burned himself and also two other patients, most likely, spot test was not performed, but if user had followed this instruction, so test spot would failed and treatment would not begun before testing, fixing and re-calibration of the device.Clinical evaluation (pi) wasn't performed yet, because the customer did not sent us incident form, thus lumenis is reporting the event in an 'abundance of caution'.There is no additional information regarding the system that can help to understand the root cause of the adverse event.Should additional significant information become available, the complaint record will be updated accordingly and a follow-up medwatch report will be submitted.

• Brand Name: LIGHTSHEER DESIRE LASER SYSTEM
• Common Device Name: SOLID STATE AESTHETIC LASER DELIVERY DEVICE
• Manufacturer (Section D): LUMENIS BE; 6 hakidma st.; po box 240; yokneam, isr 20692 04; IS 2069204
• Manufacturer (Section G): LUMENIS BE; 6 hakidma st.; po box 240; yokneam, 20692 04; IS 2069204
• Manufacturer Contact: roman vernik ; 6 hakidma st.; po box 240; yokneam, 20692-04 ; IS 2069204
• MDR Report Key: 12809780
• Report Number: 3004135191-2021-00075
• Device Sequence Number: 5484388
• Product Code: GEX
• UDI-Device Identifier: 07290109140384
• UDI-Public: 07290109140384
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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
• Remedial Action: Inspection,Other
• Type of Report: Initial
• Report Date (Section B): 11/15/2021

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: Health Professional
• Device Model Number: LIGHTSHEER DESIRE LASER SYSTEM
• Device Catalogue Number: GA-1170000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/18/2021
• Initial Report FDA Received Date: 11/15/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/09/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown