MAUDE Adverse Event Report: CANDELA CORPORATION NORDLYS; NORDLYA

Model Number	9SYS7751
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Scar Tissue (2060)
Date of Event	06/03/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A customer at a clinic in france reported an adverse event following treatment of a male patient with fitzpatrick skin type 4.The patient received nordlys nd:yag treatment of vascular lesions on the top of the nose resulting in scars.This was the patient's second treatment.The patient had no relevant patient history, no recent sun exposure; the skin was cleaned with micellar water and treated with nd:yag 1064, 3 mm spot size, a fluence of 259.9 j/cm2, and 32 ms pusle duration with zero pulse delay.Vessels were treated with one (1) pulse if small vessel and two (2) pulses if long vessel.The patient had a "classic vasoconstriction" reaction post-treatment and was provided cicalfate.The doctor is treating the scars with non-ablative fractional laser (nafl) and expects the injury to heal.Per review by candela medical director, the scar can be improved with resurfacing at a later date and will not affect function; however, the defect is deep and therefore, candela is reporting this complaint.
Additional Manufacturer Narrative
D4 correction: device serial number has been corrected to (b)(6).D4 udi added.Complaint investigation: initial event reported crusting, loss of substance, and scarring of a patient following treatment.Per field service engineer (fse) device evaluation note, the device was inspected and no issues were found.Based upon evaluation by the fse, the system would not have contributed to the reported event.Per nordlys user's manual, under 2.7.2 adverse effects of nd:yag lasers: nd:yag lasers have been used for many years for treatment of leg veins.The following side effects which are harmless acute reactions that resolve within a week following treatment are reported: · more rare reactions were superficial erosions, and crusting.The nordlys user's manual notes the following underneath workflow for nd:yag treatments: as laser treatment has a small therapeutic window then adjustment of the settings must be taken in small steps.Any adjustment should be governed by the skin reaction and patient response.Never repeat shots on the same treatment area, as this can lead to tissue damage or scarring.Therefore, the most probable cause for this event is known inherent risk of device, indicating that the reported adverse event is known and documented in the labeling (including both short or long term known complications or adverse reactions).Review of risk management documents demonstrate that the reported risk is captured and assessed.No further corrective actions required for this complaint at this time.Risk information is then subject to periodic risk reviews and trend tracking, which may require additional actions and/or review.

• Brand Name: NORDLYS
• Common Device Name: NORDLYA
• Manufacturer (Section D): CANDELA CORPORATION; 251 locke drive; marlborough MA 01752
• Manufacturer (Section G): CANDELA CORPORATION; 251 locke drive; marlborough MA 01752
• Manufacturer Contact: greg wallender ; 251 locke drive; marlborough, MA 01752 ; 5083580463
• MDR Report Key: 22561353
• Report Number: 3016496662-2025-00003
• Device Sequence Number: 4021758
• Product Code: GEX
• UDI-Device Identifier: 00817495023434
• UDI-Public: (01)00817495023434(11)210810
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K150907
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/13/2025

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: 9SYS7751
• Device Catalogue Number: 9SYS7751
• 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: 06/24/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/21/2025
• Supplement Report FDA Received Date: 08/13/2025
• 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: Male