MAUDE Adverse Event Report: ARTHREX, INC. 4K SYNERGYID CAMERA HEAD, AUTOCLAVABLE; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number 4K SYNERGYID CAMERA HEAD, AUTOCLAVABLE

Device Problem Overheating of Device (1437)

Patient Problem Superficial (First Degree) Burn (2685)

Event Date 12/07/2021

Event Type  Injury  

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 Description

On (b)(6) 2021 it was reported by a sales representative via sems that an ar-3200-0025 synergy console was involved in case when a patient was burned.Additional information provided 12/09/2021: the case was finished as planned with no known incident.Approximately 15 minutes post op, it was brought to our attention via the surgical tech in the room that the patient had sustained a burn injury and they believed it to be due to the heat level of our light cord / light post connection.

• Brand Name: 4K SYNERGYID CAMERA HEAD, AUTOCLAVABLE
• Type of Device: 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: 13525205
• MDR Text Key: 285609600
• Report Number: 1220246-2022-04438
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 00888867348844
• UDI-Public: 00888867348844
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K202582
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 02/14/2022

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
• Device Operator: Health Professional
• Device Model Number: 4K SYNERGYID CAMERA HEAD, AUTOCLAVABLE
• Device Catalogue Number: AR-3210-0033
• Device Lot Number: 12494901
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 01/25/2022
• Initial Date FDA Received: 02/14/2022
• Date Device Manufactured: 01/20/2021
• Is the Device Single Use?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other