MAUDE Adverse Event Report: ARTHREX, INC. 4K SYNERGYUHD4 BB CAMERA HEAD,AUTOCLAV; LAPAROSCOPE

Model Number	4K SYNERGYUHD4 BB CAMERA HEAD,AUTOCLAV
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/02/2023
Type of Reportable Event	Malfunction
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.(no problem found) the evaluation did not identify any issues relevant to the reported event.See attached thermal test form.
Event or Problem Description
It was reported on (b)(6) 2023 by a sales representative via sems that an ar-3210-0029 camera is getting hot and shaking a lot.Case involvement, no patient effect.

• Brand Name: 4K SYNERGYUHD4 BB CAMERA HEAD,AUTOCLAV
• 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: 19055964
• Report Number: 1220246-2024-01852
• Device Sequence Number: 6992499
• Product Code: GCJ
• UDI-Device Identifier: 00888867216570
• UDI-Public: 00888867216570
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 04/05/2024

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 BB CAMERA HEAD,AUTOCLAV
• Device Catalogue Number: AR-3210-0029
• Device Lot Number: 118181
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/31/2018
• 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