MAUDE Adverse Event Report: ARTHREX, INC. 4K SYNERGYUHD4 C-MOUNT CAMERA HEAD, AUTO; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	4K SYNERGYUHD4 C-MOUNT CAMERA HEAD, AUTO
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/15/2021
Type of Reportable Event	Malfunction
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.
Event or Problem Description
It was reported that the device overheated.There was no harm or adverse event for patient, operator or third party reported.No further information received.Update 30-nov-2021: it was confirmed that the error occurred during the surgery.The patient was not injured but the camera head was so warm that the camera drape melted.
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.
Event or Problem Description
It was reported that the device overheated.There was no harm or adverse event for patient, operator or third party reported.No further information received.Update 30-nov-2021: it was confirmed that the error occurred during the surgery.The patient was not injured but the camera head was so warm that the camera drape melted.
Additional Manufacturer Narrative
The device was subjected to functional testing and all functional criteria were met.The device was heated to 176f and met all functional and button criteria.Burn-in was performed for 4 hours.Again, all functional criteria were met.The reported event of "the device overheated" was not confirmed.

• Brand Name: 4K SYNERGYUHD4 C-MOUNT CAMERA HEAD, AUTO
• 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: 13053750
• Report Number: 1220246-2021-04124
• Device Sequence Number: 20129882
• Product Code: GCJ
• UDI-Device Identifier: 00888867197053
• UDI-Public: 00888867197053
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K153218
• 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,Followup
• Report Date (Section B): 04/27/2022

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 C-MOUNT CAMERA HEAD, AUTO
• Device Catalogue Number: AR-3210-0025
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/29/2021
• Supplement Date Received by Manufacturer: 11/29/2021
• Initial Report FDA Received Date: 12/21/2021
• Supplement Report FDA Received Date: 04/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown