MAUDE Adverse Event Report: ARTHREX, INC. 4K SYNERGYUHD4 BB CAMERA HEAD,AUTOCLAV; LAPAROSCOPE

Model Number	4K SYNERGYUHD4 BB CAMERA HEAD,AUTOCLAV
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	Superficial (First Degree) Burn (2685)
Date of Event	07/19/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On 7/25/2023, it was reported by a facility representative via sems that an ar-3210-0029 4k synergyuhd4 bb camera head got hot and overheated during a procedure.It was discovered during a case that the patient got a burn mark/spot due to the camera/cord being too hot, not indicated as to where on the patient.They were not sure if it was the camera cord or the camera itself that was having issues.This occurred during use in an unspecified procedure.Additional information has been requested.On 8/2/2023, the facility representative stated the following information via email: this occurred during a left knee acl reconstruction procedure on (b)(6) 2023.The severity of the patient's burn was 1st degree, the staff did not obtain any burns.It was determined that when completing the case, the camera head did not overheat, but the blue light cord did, an ar 3240 -5027 fused light cable with lot number wo178440.The procedure was completed successfully, and there was no other impact reported.
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 identify any issues relevant to the reported event.

• Brand Name: 4K SYNERGYUHD4 BB CAMERA HEAD,AUTOCLAV
• 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: 17606150
• Report Number: 1220246-2023-07603
• Device Sequence Number: 6139351
• Product Code: GCJ
• UDI-Device Identifier: 00888867216570
• UDI-Public: 00888867216570
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K153218
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 10/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 4K SYNERGYUHD4 BB CAMERA HEAD,AUTOCLAV
• Device Catalogue Number: AR-3210-0029
• Device Lot Number: 10204885
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/25/2023
• Supplement Date Received by Manufacturer: 07/25/2023
• Initial Report FDA Received Date: 08/23/2023
• Supplement Report FDA Received Date: 10/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/23/2018
• 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
• Patient Sex: Unknown