MAUDE Adverse Event Report: ARTHREX, INC. CCU, ARTHREX SYNERGY UHD4; LAPAROSCOPE

Model Number	CCU, ARTHREX SYNERGY UHD4
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2025, a sales representative reported via (b)(4) that an ar-3200-0021 synergyuhd4 camera control unit had a burning smell and was physically damaged where the light cord was inserted into the unit.The end of the light cord seemed burned and was black at the end, as well as the console's plug-in.The case was completed using another light cord, and at the end of the case, the same issue occurred.It is unknown if the two light cords used in the case were arthrex products.There was no injury to the patient, surgeon, or facility staff.The case was delayed for a couple of minutes, and there was no information on added anesthesia administered to the patient.There was no rep present at the case.This was discovered during a urology procedure on (b)(6) 2025, with no report of patient harm.Additional information was received on 01/13/2025: the two unknown light cords reported during this procedure are non-arthrex products and were discarded.No additional anesthesia was administered to the patient.
Additional Manufacturer Narrative
(cleaning) due to the visible residue on the surface of the light engine led, the reported event of "an ar-3200-0021 synergyuhd4 camera control unit had a burning smell and was physically damaged where the light cord was inserted into the unit.The end of the light cord seemed burned and was black at the end, as well as the console's plug-in.The case was completed using another light cord, and at the end of the case, the same issue occurred" was confirmed.The most likely cause was determined to be contaminant on the third-party light guides.

• Brand Name: CCU, ARTHREX SYNERGY UHD4
• 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: 21320896
• Report Number: 1220246-2025-00237
• Device Sequence Number: 12742083
• Product Code: GCJ
• UDI-Device Identifier: 00888867197022
• UDI-Public: (01)00888867197022(11)190319(10)10285973
• Combination Product (Y/N): N
• Initial Reporter State: WY
• Initial Reporter Country: US
• PMA/510(K) Number: K153218
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 02/06/2025

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 UHD4
• Device Catalogue Number: AR-3200-0021
• Device Lot Number: 10285973
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/05/2025
• Initial Report FDA Received Date: 02/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/19/2019
• 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