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

Model Number	CCU, SYNERGY VISION
Medical Device Problem Code	Device Emits Odor (1425)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device smells strongly burnt.This was noticed before the surgery.There was no harm for patient, operator or third party.There was no case involvement.No further information received.Update (b)(4) 21-mar-2025: further information was received: this was noticed before the surgery, however, they used the device anyway as they could not determine where the burning smell was coming from.It is still not clear where the smell came from.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: (device not returned) the most likely cause for the reported event is a light engine failure.

• Brand Name: CCU, SYNERGY VISION
• 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: 21663600
• Report Number: 1220246-2025-01101
• Device Sequence Number: 7564918
• Product Code: GCJ
• UDI-Device Identifier: 00888867443761
• UDI-Public: (01)00888867443761(11)240816(10)15296178
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K233451
• 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): 06/27/2025

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
• Operator of Device: Health Professional
• Device Model Number: CCU, SYNERGY VISION
• Device Catalogue Number: AR-3200-0026
• Device Lot Number: 15296178
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/24/2025
• Supplement Date Received by Manufacturer: 06/05/2025
• Initial Report FDA Received Date: 03/21/2025
• Supplement Report FDA Received Date: 06/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/16/2024
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown