MAUDE Adverse Event Report: ARTHREX, INC. CCU, ARTHREX SYNERGY ID; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	CCU, ARTHREX SYNERGY ID
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	12/06/2021
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2021 it was reported by a sales representative via sems that an ar-3200-0025 synergy console was used in a case and the patient had a circular burn.This burn was discovered from a 2 week post-op follow up exam.The procedure was a gastric bypass on a female patient on (b)(6) 2021.
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
(no problem found) the evaluation did not confirm the reported event as the device worked as intended.

• Brand Name: CCU, ARTHREX SYNERGY ID
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• 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: vik bajnath ; 8009337001
• MDR Report Key: 13396735
• Report Number: 1220246-2022-04358
• Device Sequence Number: 4950704
• Product Code: GCJ
• UDI-Device Identifier: 00888867351189
• UDI-Public: 00888867351189
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K202582
• 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): 07/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: CCU, ARTHREX SYNERGY ID
• Device Catalogue Number: AR-3200-0025
• Device Lot Number: 14127688
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/13/2022
• Supplement Date Received by Manufacturer: 01/13/2022
• Initial Report FDA Received Date: 01/31/2022
• Supplement Report FDA Received Date: 07/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/21/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown