MAUDE Adverse Event Report: ARTHREX, INC. 4K SYNERGYUHD4 ULTRA C-MOUNT, AUTOCLAVAB; LAPAROSCOPE

Model Number	4K SYNERGYUHD4 ULTRA C-MOUNT, AUTOCLAVAB
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	06/12/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2023, it was reported by a sales representative via sems that an ar-3210-0032 camera head overheated.This occurred during a case and burned the surgeon.There was no additional information provided, additional information has been requested.
Additional Manufacturer Narrative
The contribution of the device to the reported event has not yet been determined as the device has not been returned for evaluation at this time.A follow-up report will be submitted, including a most likely cause if a root cause can not be determined.
Additional Manufacturer Narrative
(manufacturing assembly error) the evaluation determined that the reported event may have been caused by a manufacturing assembly error.

• Brand Name: 4K SYNERGYUHD4 ULTRA C-MOUNT, AUTOCLAVAB
• 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: 17246738
• Report Number: 1220246-2023-07018
• Device Sequence Number: 4872255
• Product Code: GCJ
• UDI-Device Identifier: 00888867276505
• UDI-Public: 00888867276505
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 10/31/2024

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: 4K SYNERGYUHD4 ULTRA C-MOUNT, AUTOCLAVAB
• Device Catalogue Number: AR-3210-0032
• Device Lot Number: 14950337
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/12/2023
• Supplement Date Received by Manufacturer: 06/20/2024
• Initial Report FDA Received Date: 07/03/2023
• Supplement Report FDA Received Date: 10/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/22/2022
• 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