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	04/07/2024
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 and patient photo.Incident form has been received in lumenis.An examination of the subject device was performed by lumenis service engineer after verifying all system functions including handpiece cooling effect.It was found that there is no cooling effect.Recomended to replace the ipl handpiece.Also recomended to check more for dust and do maintenance.Per gso expert, in case of cooling issue, the temperature of the lightguide will increase up to 50° c and will raise an error that will stop the system functioning (no energy emission).Thus, this malfunction should not lead to serious injury if it would be recur.The device was installed on (b)(6) 2016 and no pm was performed by lumenis since (b)(6) 2017.Lumenis highly recommends an annual pm check in a timely manner to assure continued proper operation of the device.A lumenis clinical healthcare director concluded: "this is a report on a patient injury resulting from the use of a lumenis device the information provided is inconsistent in relation to the device used and the nature of the injury and its severity were not described in the report.Device cooling malfunction in the ipl handpiece however it is not clear from the information available if this was the handpiece that led to an injury.Additional information is required for a more accurate medical assessment.".Following the clinical director advice, lumenis contacted again with the customer in order to achieve more relevant clinical information for accurate clinical evaluation.However the customer refused to send any additional information.Accordingly and based on the information received to date, does not confirm that a serious injury had occurred.Also there was a cooling issue that should not lead to serious injury to patient.Based on 1010197_r risk analysis and report for m22 and stellar platform - section #1.1.9 - cooling system failure, the risk is within the acceptable risk.Because of the lack of information 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.Lumenis is closing this complaint, but will continue to monitor this failure mode; complaint trending will continue to monitor per global complaint handling sop (doc no.(b)(4)) and per post marketing surveillance procedure (doc no.(b)(4)).
Event or Problem Description
Lumenis received an adverse event report on a patient who sustained injury following treatment by m22 device.

• Brand Name: M22
• Common Device Name: INTENSE PULSE LIGHT DELIVERY DEVICE
• Manufacturer (Section D): LUMENIS BE LTD; 9 hakidma street; po box #426; yokneam, isr 20692 36; IS 2069236
• Manufacturer (Section G): LUMENIS BE LTD; 9 hakidma street; po box #426; yokneam, isr 20692 36; IS 2069236
• Manufacturer Contact: yossi avnilov ; 9 hakidma street; po box #426; yokneam, isr 20692-36 ; IS 2069236
• MDR Report Key: 19220299
• Report Number: 3021349626-2024-00006
• Device Sequence Number: 20589496
• Product Code: GEX
• UDI-Device Identifier: 07290109140360
• UDI-Public: 07290109140360
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Other Health Care Professional
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date (Section B): 05/01/2024

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/07/2024
• Initial Report FDA Received Date: 05/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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