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

Model Number	CCU, SYNERGY VISION CONNECT
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/05/2026
Type of Reportable Event	Malfunction
Event or Problem Description
On 05-mar-2026, a facility representative reported via (b)(4) that an ar-3200-0027 synergy vision connect ccu was overheating with the smell of burning plastic from inside the unit.No case was involved.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.No physical problems were apparent during the visual evaluation.Functional evaluation: ccu dhg250063 was subjected to functional testing per wi-000229753, fco procedure, ccu, arthrex synergy vision (gen3) using a known good test camera head, a known good test tablet, a known good test camera head and a known good test nano handpiece.Multiple test cases were created, and no functional issues were observed with the exception of the automated mainboard test (amt), which failed at step 12.This test evaluates the jtag interface from the som to the fpga.This test was subsequently repeated multiple times.The failure could not be replicated.(note: this failure will be noted as unrelated to reported event.The associated cause is unknown.) the ccu was burned in for 2 hours with the light engine active, and no functional issues were observed.It was then power cycled several times and left powered on overnight with the cover on.The ccu was reevaluated and no functional issues were noted.No evidence of overheating or thermal damage was observed.The interior of the device was visually examined.No evidence of smoking, burning or any other thermal damage was observed.Finally, the device was subjected to an electrical safety test.All related acceptance criteria were met.In reference to the customer complaint reported, "an ar-3200-0027 synergy vision connect ccu was overheating with the smell of burning plastic from inside the unit.No case was involved;" since investigative findings were not able to replicate the customer's complaint, the complaint will be considered 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: 24689926
• Report Number: 1220246-2026-01652
• Device Sequence Number: 13174949
• Product Code: GCJ
• UDI-Device Identifier: 00888867443778
• UDI-Public: (01)00888867443778(11)250829(10)15490486
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K241361
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 04/20/2026

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: 15490486
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/05/2026
• Supplement Date Received by Manufacturer: 04/16/2026
• Initial Report FDA Received Date: 03/25/2026
• Supplement Report FDA Received Date: 04/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/29/2025
• Is the Device Labeled for Single Use? (Y/N): No
• 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