MAUDE Adverse Event Report: ARTHREX, INC. 4K SYNERGYUHD4 C-MOUNT BB CAMERA HD, AUT; LAPAROSCOPE

Model Number	4K SYNERGYUHD4 C-MOUNT BB CAMERA HD, AUT
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/05/2022
Type of Reportable Event	Malfunction
Event or Problem Description
On 04/18/2022, it was reported by an arthrex employee via sems that an ar-3210-0030 4k synergyuhd4 c-mount bb camera head was overheating during use, there was no patient, user, or third-party injury.To troubleshoot, the camera head was tested with a temperature sensor attached to it.The camera head showed an increase in temperature to 43 degrees celcius after 45 minutes of use.This was discovered during use on 04/06/2022 with no case/patient involvement.Additional information has been requested.On 04/21/2022, the arthrex employee stated the following information via email: the event occurred during the end of a knee arthroscopy on (b)(6) 2022.The overheating was detected at the end of the procedure by the surgeon and after this incident, it was tested by arthrex mexico in a maintenance visit on 04/06/2022.Nobody was harmed by the overheating of the device, it was just a comment of the surgeon that the camera head was hot.
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.(not confirmed) the evaluation did not reveal any issues relevant to the reported event.See attached thermal test results.

• Brand Name: 4K SYNERGYUHD4 C-MOUNT BB CAMERA HD, AUT
• 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: emily shafer ; 8009337001
• MDR Report Key: 19006043
• Report Number: 1220246-2024-01737
• Device Sequence Number: 21175461
• Product Code: GCJ
• UDI-Device Identifier: 00888867230316
• UDI-Public: 00888867230316
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: K153218
• 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
• Report Date (Section B): 03/29/2024

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 C-MOUNT BB CAMERA HD, AUT
• Device Catalogue Number: AR-3210-0030
• Device Lot Number: 10313840
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/06/2022
• Initial Report FDA Received Date: 03/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/29/2018
• 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