MAUDE Adverse Event Report: LUTRONIC CORPORATION XERF

Catalog Number	F1101300330
Medical Device Problem Codes	Material Deformation (2976); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Burn(s) (1757)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the controversies event in (b)(6), a patient received burns during electrocoagulation treatment on the face with a xerf device.Review of the treatment parameters used were found to be within the recommended clinical guidelines.Review of the supplied image of the tip observed what appeared to be a burn mark.It is unknown what caused this visual discrepancy.Images of the patient have been requested to review with the cynosure lutronic medical director, however, despite multiple attempts to obtain the requested images, none have not been supplied at this time.At this time, it is unknown what contributed to the reported malfunction and burning observed damage to the tip observed in the provided image.It is unknown what caused this observed defect to the tip.The defect was observed but unable to be verified if it contributed to the reported burning.A final mdr will be submitted once investigation has been completed.Since a reported malfunction and serious injury occurred, we are reporting this as an initial mdr.
Event or Problem Description
This is a follow up report to medwatch 1222993-2025-00036 due to device investigation completed.Investigation confirmed the root cause as interference from the nozzle of the automated adhesive dispenser during the application of adhesive around the tip causing micro-scratches.The micro-scratches on the tip surface, on a rare occasion can lead to pvdf film damage which may result in patient injury.To correct the issue the nozzle of the automated adhesive dispenser was adjusted to prevent interference during the application of adhesive around the tip and 100% visual, in-process inspection for evidence of micro-scratches was introduced to the process.

• Brand Name: XERF
• Common Device Name: XERF
• Manufacturer (Section D): LUTRONIC CORPORATION; lutronic center; 219 sowon-ro; deogyang-gu, goyang-si 10534 ; KS 10534
• MDR Report Key: 23027970
• Report Number: 1222993-2025-00036
• Device Sequence Number: 9427856
• Product Code: GEI
• UDI-Device Identifier: 08809447657981
• UDI-Public: 08809447657981
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/22/2025
• Report Date (Section F): 10/22/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: F1101300330
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 08/16/2025
• Event Location: Other
• Date Report to Manufacturer: 10/22/2025
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/11/2025
• Supplement Report FDA Received Date: 10/22/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 10/22/2025