MAUDE Adverse Event Report: ARTHREX, INC. SALES LEVEL,CCU,SYNERGY HD3,TURRET; LAPAROSCOPE

Model Number	SALES LEVEL,CCU,SYNERGY HD3,TURRET
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/23/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2023, it was reported by a sales representative via sems-06014189 that an ar-3200-0001t synergy console is having a problem with the image on the screens during arthroscopies.When using the apollo rf burner or other arthroscopic electrocautery, the image on the screen flickers, disappears, has lines running through it, or is otherwise distorted.Tech support is troubleshooting to resolve the issue.The patient was not affected.
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.(device not returned) the most likely cause for the reported event is a failing isolation board.

• Brand Name: SALES LEVEL,CCU,SYNERGY HD3,TURRET
• 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: 17763494
• Report Number: 1220246-2023-07927
• Device Sequence Number: 6995659
• Product Code: GCJ
• UDI-Device Identifier: 00888867029163
• UDI-Public: 00888867029163
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 12/06/2024

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: SALES LEVEL,CCU,SYNERGY HD3,TURRET
• Device Catalogue Number: AR-3200-0001T
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/23/2023
• Supplement Date Received by Manufacturer: 11/06/2024
• Initial Report FDA Received Date: 09/18/2023
• Supplement Report FDA Received Date: 12/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown