MAUDE Adverse Event Report: LUMENIS BE LTD. M22; STELLAR M22 FOR INTENSE PULSED LIGHT DELIVERY DEVICE, PRODUCT CODE: GEX

Model Number	M22
Medical Device Problem Code	Device Handling Problem (3265)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	12/05/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Lumenis received an adverse event report on a patient who sustained injury following treatment by m22 device.
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.Later, (b)(6) advised: "(b)(6) hands were processed by a third party, please see the attached photo.The severity of the problem and the uncertainty of subsequent use were explained to the customer on site, and the customer was advised to use the original handpieces.Also, their filter was seriously damaged and it was recommended to replace it.I would like to ask the business to follow up.Mr.(b)(6) from their hospital said on the spot that he was not sure which piece of equipment had injured the customer.It was possible that they had made a mistake." gso representative advised: "1.There is different between the error log file to hp reading screen.Pulses number 66 vs 94822 pulses - that abnormal.2.The hp has different labels then lumines using.3.Hp shells are partially open - almost broken.4.Above justified that the hp is having abnormal parameters which support the claim of the ce that the hp is not made/repaired by lumines standards.5.Filters should be used following lumines standard - if they are in poor conditions - it is user responsibility as he not following lumines guide um.6.It look as missed used issue.7.We can see that original hp s/n was (b)(6) - has 66 pulses.8.Second hp has s/n (b)(6) having 16411 pulses.9.We can see that original hp s/n was (b)(6) - has 94822 pulses." regional quality manager advised: "the hospital can't remember which device injured the patient, maybe it was mixed up, maybe it wasn't this device (32883).The patient did not cooperate in providing relevant information to assist the hospital in completing documents such as incident forms and photos of injuries.At the hospital site, engineer found that the ipl hand piece's casing may have been opened by non-lumenis person." based on this, neither incident form nor photo of the injury will be provided.According to the provided information there is no device malfunction found, but poor condition of the device or its component caused by user error due to inappropriate handling and/or and lack of timely maintenance.It can be a possible reason for ae.Based on risk file (b)(4) risk analysis and report for m22 and stellar platform, par.#18- reasonably foreseeable misuse, can lead to tissue damage, but this risk has been evaluated and found within acceptable limits.Since no essential information was received within period which is determined for reportability, lumenis is reporting this 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.All relevant information was sent to regional representatives in china to decide if this case should be reportable to the nmpa.Upon receiving of their confirmation, this complaint will be updated and closed.

• Brand Name: M22
• Common Device Name: STELLAR M22 FOR INTENSE PULSED LIGHT DELIVERY DEVICE, PRODUCT CODE: GEX
• Manufacturer (Section D): LUMENIS BE LTD.; 9 hakidma st.; p.o.b 426; yokneam illit, israel 20692 36; IS 2069236
• Manufacturer (Section G): LUMENIS BE LTD.; 9 hakidma st.; p.o.b 426; yokneam illit, israel 20692 36; IS 2069236
• Manufacturer Contact: roman vernik ; 9 hakidma st.; p.o.b 426; yokneam illit, israel 20692-36 ; IS 2069236
• MDR Report Key: 18299342
• Report Number: 3021349626-2023-00021
• Device Sequence Number: 3240610
• 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: 505
• Type of Report: Initial
• Report Date (Section B): 12/11/2023

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-0005201CN
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/05/2023
• Initial Report FDA Received Date: 12/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/11/2022
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Prefer Not To Disclose
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian