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

Model Number	CCU, ARTHREX SYNERGY ID
Medical Device Problem Code	Smoking (1585)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/06/2024
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 an arthroscopic surgery the device has started to smolder at the light source.There was no harm for patient, operator or third party.The surgery was finished successfully without the device.It was not necessary to switch the surgical technique or do a second surgery.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.(contamination) this evaluation determined that the reported event most likely occurred due to contamination on the face of the light engine led.

• Brand Name: CCU, ARTHREX SYNERGY ID
• 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: 19624170
• Report Number: 1220246-2024-06462
• Device Sequence Number: 6434313
• Product Code: GCJ
• UDI-Device Identifier: 00888867351189
• UDI-Public: 00888867351189
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K202582
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/12/2025

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, ARTHREX SYNERGY ID
• Device Catalogue Number: AR-3200-0025
• Device Lot Number: 15071111
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/06/2024
• Supplement Date Received by Manufacturer: 08/07/2024
• Initial Report FDA Received Date: 06/27/2024
• Supplement Report FDA Received Date: 05/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/31/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown