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

Model Number	CCU, ARTHREX SYNERGY UHD4
Medical Device Problem Code	Computer Software Problem (1112)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/14/2023
Type of Reportable Event	Malfunction
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.
Event or Problem Description
On 11/14/2023, it was reported by a sales representative via (b)(4) that an ar-3200-0021 ccu had issues after applying the 4.17.5 update.There was green static while using multiple camera heads (these camera heads were then tested on a different console and had no issues), cases ending unexpectedly, followed by a new case auto-starting with patient information from a separate room, duplicated cases, and no photos saving from the cases.Before the upgrade, the account had no issues with their ccu.This was discovered during their first case since the update on 11/14/2023, with no reported adverse event or patient harm.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.(no problem found) the evaluation did not identify any issues relevant to the reported event.

• 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: emily shafer ; 8009337001
• MDR Report Key: 18292567
• Report Number: 1220246-2023-09302
• Device Sequence Number: 20507426
• Product Code: GCJ
• UDI-Device Identifier: 00888867197022
• UDI-Public: 00888867197022
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,Followup
• Report Date (Section B): 12/03/2024

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: CCU, ARTHREX SYNERGY UHD4
• Device Catalogue Number: AR-3200-0021
• Device Lot Number: 10200490
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/14/2023
• Supplement Date Received by Manufacturer: 01/09/2024
• Initial Report FDA Received Date: 12/08/2023
• Supplement Report FDA Received Date: 12/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/05/2018
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown