MAUDE Adverse Event Report: ARTHREX, INC. SYNERGY VISIONARY HDR C-MOUNT CAMERA; LAPAROSCOPE

Model Number	SYNERGY VISIONARY HDR C-MOUNT CAMERA
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
It was reported that the device overheated and could not be held in the hand.This was noticed before the surgery.There was no harm for patient, operator or third party.No further information received.Update (b)(6) 11-nov-25: new information was provided that the device overheated during an endoscopic surgery on (b)(6) 2025.Per complaint reporter there was no harm for patient, operator or third party.The surgery was finished successfully.It was not necessary to switch the surgical technique or do a second surgery.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.(not confirmed) the evaluation did not reveal any issues relevant to the reported event.

• Brand Name: SYNERGY VISIONARY HDR C-MOUNT CAMERA
• Common Device Name: LAPAROSCOPE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: jared engle ; 8009337001
• MDR Report Key: 23647768
• Report Number: 1220246-2025-05196
• Device Sequence Number: 4769571
• Product Code: GCJ
• UDI-Device Identifier: 00888867445383
• UDI-Public: (01)00888867445383(11)240826(10)15305395
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K241361
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 02/10/2026

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
• Operator of Device: Health Professional
• Device Model Number: SYNERGY VISIONARY HDR C-MOUNT CAMERA
• Device Catalogue Number: AR-3210-0034
• Device Lot Number: 15305395
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/06/2025
• Supplement Date Received by Manufacturer: 01/27/2026
• Initial Report FDA Received Date: 11/25/2025
• Supplement Report FDA Received Date: 02/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/26/2024
• 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
• Patient Sex: Unknown