MAUDE Adverse Event Report: LUMENIS BE LTD M22; INTENSE PULSE LIGHT DELIVERY DEVICE

Model Number	M22
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	10/11/2022
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.Customer reported that the ipl hp is running hot and burned a couple of employees.Since the customer did not provide incident form/s this case will be threaten in one single complaint.The device ga-0005200:21728 was installed in the facility on (b)(6) 2018 and the last pm was done on (b)(6) 2018.It's strongly recommended by lumenis to perform preventive maintenance (pm) early and initiating of this activity lays on customer's responsibility.Service team was requested to test the device and they advised: "the customer is a billable customer as that is what they elect on every laser.We have made several attempts to get them covered and they refuse to cover any of their lasers under service contract.They only call when their lasers go down.Ex.They went 15 months without a pm on this laser prior to last service on this laser.The service fee for this customer is $4500 for travel and labor.I am not sure what we can do outside of provide them with the quote, have them sign, pay and get ian out there asap".Lumenis representative contacted with customer, and then dr.(b)(6) claimed to him that they hadn't used the system since the last service in june meaning approx.4 month, then burned customers at the first use so they assumed we would "cover" the system for that period.Finally, the customer refused to pay for service.According to the received information, the customer decided not to perform timely pm, thus lumenis cannot guarantee the proper operation of the device.Since the customer refused to pay for testing of the device, we cannot evaluate the status of the device as well as to confirm that a reported adverse event caused by the system malfunction.Moreover, since customer claimed that they did not use the device since last service visit and device was in proper working condition, reported malfunction is not reasonably.Since the customer refused to test the device and did not provide an incident form, lumenis is reporting this event as in 'abundance of caution'.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 patients who sustained burns following treatment by m22 device.

• Brand Name: M22
• Common Device Name: INTENSE PULSE LIGHT DELIVERY DEVICE
• Manufacturer (Section D): LUMENIS BE LTD; 6 hakidma st.; po box 240; yokneam, isr 20692 04; IS 2069204
• Manufacturer (Section G): LUMENIS BE.LTD; hakidma street 6; po box 240; yokneam, 20692 04; IS 2069204
• Manufacturer Contact: roman vernik ; hakidma street 6; po box 240; yokneam, 20692-04 ; IS 2069204
• MDR Report Key: 15730263
• Report Number: 3021349626-2022-00004
• Device Sequence Number: 2919639
• Product Code: GEX
• UDI-Device Identifier: 07290109140360
• UDI-Public: 07290109140360
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K170060
• 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: Administrator/Supervisor
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date (Section B): 11/03/2022

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: M22
• Device Catalogue Number: GA-0005200
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/11/2022
• Initial Report FDA Received Date: 11/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/20/2018
• 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