MAUDE Adverse Event Report: LUMENIS LTD. LUMENIS M22 SYSTEM; POWERED LASER SURGICAL INSTRUMENT

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	07/19/2021
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.Ipl handpiece checked for any cooling issues.Chilltip found to be functioning normally.Output from ipl head checked on external meter and found to be within expected ranges across all settings and filters, with no deviant results.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.Clinical evaluation wasn't performed, since no incident form or photos were sent to lumenis.Lumenis tried several times to achieve more information from the customer, but the customer didn't respond.According to the information received there is no malfunction found on a system.Clinical evaluation wasn't performed, since no incident form or photos were sent to lumenis.Because of the lack of information(no incident form received), lumenis is reporting the event in an '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 patient who sustained burn following treatment by m22 device.

• Brand Name: LUMENIS M22 SYSTEM
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): LUMENIS LTD.; 6 hakidma street; po box 240; yokneam, isr 20692 ; IS 20692
• MDR Report Key: 12322319
• Report Number: 3004135191-2021-00054
• Device Sequence Number: 4507745
• Product Code: GEX
• UDI-Device Identifier: 07290109140360
• UDI-Public: 07290109140360
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 08/15/2021

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: Other
• 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: 07/19/2021
• Initial Report FDA Received Date: 08/15/2021
• 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