MAUDE Adverse Event Report: ARTHREX, INC. 4K SYNERGYUHD4 ULTRA C-MOUNT, AUTOCLAVAB; LAPAROSCOPE

Model Number	4K SYNERGYUHD4 ULTRA C-MOUNT, AUTOCLAVAB
Medical Device Problem Code	Excessive Heating (4030)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/03/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On 02/03/2023, it was reported by a facility representative via sems that a ar-3210-0032 camera head got very hot, and turned off.This occurred during a case, with no patient effect reported.
Additional Manufacturer Narrative
This 3500a record is submitted to comply with an fda 483 inspectional observation issued to arthrex inc on may 5, 2023.Arthrex has reassessed the reportability decisions made on historical complaint records using revised criterion.This 3500a document is a result of the reassessment.The complaint device was not received for evaluation.Based off the information provided, the most likely cause for the reported failure can be attributed to a failing headboard.

• Brand Name: 4K SYNERGYUHD4 ULTRA C-MOUNT, AUTOCLAVAB
• 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: 19538474
• Report Number: 1220246-2024-05807
• Device Sequence Number: 8412525
• Product Code: GCJ
• UDI-Device Identifier: 00888867276505
• UDI-Public: 00888867276505
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K153218
• 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
• Report Date (Section B): 06/14/2024

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: 4K SYNERGYUHD4 ULTRA C-MOUNT, AUTOCLAVAB
• Device Catalogue Number: AR-3210-0032
• Device Lot Number: 117653
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/03/2023
• Initial Report FDA Received Date: 06/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/22/2017
• 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