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	Overheating of Device (1437)
Health Effect - Clinical Code	Partial thickness (Second Degree) Burn (2694)
Date of Event	10/12/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of this complaint confirmed the event summary code selection.The contribution of the device to the reported event could not be determined as the device was not available for evaluation.The cause of the event could not be determined from the information available and without device evaluation.The most likely cause of the failure is incorrect/loose installation of the video or power cables to the console.As no further investigation was able to be performed no change in harm was identified.Complaint trending for this event will be performed per wi-000100100.
Event or Problem Description
On 10/25/2023, it was reported by an arthrex subsidiary employee via sems-06066622 that an ar-3200-0001t consoles monitor went dark and the fiber was hot.This occurred during an arthroscopic patellar dislocation plasty procedure on (b)(6) 2023, where the patient had a shallow second-degree skin scald with an area of about 1*0.5 cm and ulceration in the anterior upper tibial segment of the left calf.There are also two deep second-degree skin scalds and rupturing in the middle and upper segments, one with an area of 1*0.5cm and the other with an area of 2*2 cm.The wounds were caused by heat burning in the fiber.The case was completed several hours later.

• 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: 18163097
• Report Number: 1220246-2023-08791
• Device Sequence Number: 6541289
• Product Code: GCJ
• UDI-Device Identifier: 00888867029163
• UDI-Public: 00888867029163
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K071756
• 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): 11/17/2023

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?: 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: 10/24/2023
• Initial Report FDA Received Date: 11/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/20/2020
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown