MAUDE Adverse Event Report: ARTHREX, INC. 4K SYNERGYUHD4 BB CAMERA HEAD,AUTOCLAV; LAPAROSCOPE

Model Number	4K SYNERGYUHD4 BB CAMERA HEAD,AUTOCLAV
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/05/2025
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 during a surgery the camera gets very hot when it is used in combination with the console.It results in image failures, leading to no hdmi signal.Per complaint reporter there was no harm for patient, operator or third party.The surgery was finished successfully with the same device.No further information received.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.The reported event was confirmed.The service evaluation revealed the camera heat became hot during a long term test due to defective electronic components.The most likely cause for the observed condition can be attributed to wear and tear.

• Brand Name: 4K SYNERGYUHD4 BB CAMERA HEAD,AUTOCLAV
• 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: 23644536
• Report Number: 1220246-2025-05178
• Device Sequence Number: 21273369
• Product Code: GCJ
• UDI-Device Identifier: 00888867216570
• UDI-Public: (01)00888867216570(11)180403(10)10199952
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K153218
• 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: 4K SYNERGYUHD4 BB CAMERA HEAD,AUTOCLAV
• Device Catalogue Number: AR-3210-0029
• Device Lot Number: 10199952
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/05/2025
• Supplement Date Received by Manufacturer: 02/05/2026
• 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: 04/03/2018
• 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