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

Model Number	4K SYNERGYID CAMERA HEAD, AUTOCLAVABLE
Health Effect - Clinical Code	Superficial (First Degree) Burn (2685)
Date of Event	12/22/2022
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2022, it was reported by a sales representative via email that a patient was burned after an ar-3210-0033 camera head was placed on the patient after a laparoscopic procedure on (b)(6) 2022.The light cord and scope were disconnected, then the camera was placed on the patients skin, that resulted in a burn.No additional information was provided.Additional information requested.
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
The complaint was not confirmed from the device evaluation.The evaluation did not reveal any issue relevant to the reported event.

• Brand Name: 4K SYNERGYID CAMERA HEAD, AUTOCLAVABLE
• 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: 16120538
• Report Number: 1220246-2023-06052
• Device Sequence Number: 6505133
• Product Code: GCJ
• UDI-Device Identifier: 00888867348844
• UDI-Public: 00888867348844
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K202582
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 02/21/2023

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?: No
• Operator of Device: Health Professional
• Device Model Number: 4K SYNERGYID CAMERA HEAD, AUTOCLAVABLE
• Device Catalogue Number: AR-3210-0033
• Device Lot Number: 13009983
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/22/2022
• Supplement Date Received by Manufacturer: 12/22/2022
• Initial Report FDA Received Date: 01/09/2023
• Supplement Report FDA Received Date: 02/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/05/2021
• 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