MAUDE Adverse Event Report: LUMENIS LTD. LIGHTSHEER DESIRE; INTENSE PULSE LIGHT DELIVERY DEVICE

Model Number	LIGHTSHEER DESIRE
Medical Device Problem Code	Failure to Calibrate (2440)
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.Five (5) attempts have been made by three (3) phone calls and two (2) emails to obtain; patient treatment settings, patient information, patient photos.No incident forms nor photos were sent by the facility.A lumenis technical engineer evaluated the device and found the energy output on hs hp 20% higher than normal.The xc hp energy was within spec.The ce replaced gui, cleaned optics, calibrated hs hp and verified calibration is within lumenis spec.Also, added coolant and cleaned the bottom air screen.The vacuum air filter was in good condition.Finally, he verified system operation and it was within spec.Preventive maintenance was completed.After device calibration, the energy returned within normal operating spec.Thus, the device wasn't calibrated properly most likely due to debris on power meter or hs tip.According to user manual um-1080310, rev.E, when performing calibration: "ensure that the handpiece's sapphire tip is clean and dry, ensure that the energy meter's protective window is present and clean.Warning - the internal energy meter window must be clean to ensure accurate calibration.An unclean window will result in higher than indicated fluence, which may cause epidermal damage." no clinical evaluation was conducted as no incident forms or photos were sent to lumenis by the user facility.While the information received to date does not confirm that a serious injury occurred, because of the lack of information regarding the injury leaving a permanent impairment, the company is reporting the event in an 'abundance of caution'.Based on the information provided a root cause cannot be determined at this time.The most probable cause of the reported event is user error, a failure on the part of the device operator to follow instructions/warnings described in the device user manual.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
Customer reported that the system has left marks of the grid on patients legs.No further details in regards to the number of patients or severity.They mentioned that the system has required service for some time.

• Brand Name: LIGHTSHEER DESIRE
• Common Device Name: INTENSE PULSE LIGHT DELIVERY DEVICE
• Manufacturer (Section D): LUMENIS LTD.; 6 hakidma street; po box 240; yokneam, 20692 ; IS 20692
• MDR Report Key: 8653550
• Report Number: 3004135191-2019-00070
• Device Sequence Number: 11337471
• Product Code: GEX
• UDI-Device Identifier: 07290109140384
• UDI-Public: 07290109140384
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 05/30/2019

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 DESIRE
• Device Catalogue Number: GA-1170000
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/03/2019
• Initial Report FDA Received Date: 05/30/2019
• 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