MAUDE Adverse Event Report: ARTHREX, INC. CCU, SYNERGY VISION CONNECT; LAPAROSCOPE

Model Number	CCU, SYNERGY VISION CONNECT
Medical Device Problem Code	Device Emits Odor (1425)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/10/2025
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 ccu had a strong smell of burnt plastic.This was noticed before use.There was no harm for patient, operator or third party.There was no case involvement.No further information received.
Additional Manufacturer Narrative
No physical problems were apparent during the visual evaluation.Functional evaluation: ccu dhf240069 was subjected to functional testing per wi-000229753, fco procedure, ccu, arthrex synergy vision (gen3) using a known good test camera head and a known good test tablet, as well as a known good test camera head and a known good test nano handpiece.Upon first power up, the device was in demo mode.Multiple test cases were initiated, and no functional issues observed.The device failed step 12 of the automated main board test, which evaluates the jtag interface from the som to the fpga.The device was power cycled several times and reevaluated, and no additional functional issues were observed.The "bit error rate" test was performed for 10 minutes and no failures occurred.The device was burned in for 2 hours with the light engine active, and no functional issues were observed.No evidence of overheating or thermal damage was observed.The interior of the device was examined for evidence of burning.No evidence of burning or any other damage was observed.The evaluation did not identify any issues relevant to the reported event.The reported event is therefore not confirmed.

• Brand Name: CCU, SYNERGY VISION CONNECT
• 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: 23707906
• Report Number: 1220246-2025-05369
• Device Sequence Number: 16134090
• Product Code: GCJ
• UDI-Device Identifier: 00888867443778
• UDI-Public: (01)00888867443778(11)250829(10)NB
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: CCU, SYNERGY VISION CONNECT
• Device Catalogue Number: AR-3200-0027
• Device Lot Number: NB
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2025
• Distributor Facility Aware Date: 11/13/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/13/2025
• Supplement Date Received by Manufacturer: 02/03/2026
• Initial Report FDA Received Date: 12/03/2025
• Supplement Report FDA Received Date: 02/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/29/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown