MAUDE Adverse Event Report: ARTHREX, INC. HD SYNERGYUHD4 C-MOUNT CAMERA HEAD, AUT; LAPAROSCOPE

Model Number	HD SYNERGYUHD4 C-MOUNT CAMERA HEAD, AUT
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/21/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device is overheating and turns purple without handling the cable.There was no harm or adverse event for patient, operator or third party reported.No further information received.Update avoe 22-jul-2022: it was confirmed that the overheating of the device was not linked to any surgery and the issue with the picture was noticed during the incoming check at the office.
Additional Manufacturer Narrative
This 3500a record is submitted to comply with an fda 483 inspectional observation issued to arthrex inc on may 5, 2023.  arthrex has reassessed the reportability decisions made on historical complaint records using revised criterion.This 3500a document is a result of the reassessment.Event description: it was reported that the device is overheating and turns purple without handling the cable.The reported event was partly confirmed.The service evaluation revealed that the device gets very hot after a few minutes due to a defective electronic.However the device does not turn purple without handling the cable.

• Brand Name: HD SYNERGYUHD4 C-MOUNT CAMERA HEAD, AUT
• 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: jared engle ; 8009337001
• MDR Report Key: 19454737
• Report Number: 1220246-2024-04791
• Device Sequence Number: 7024696
• Product Code: GCJ
• UDI-Device Identifier: 00888867218239
• UDI-Public: 00888867218239
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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
• Report Date (Section B): 06/03/2024

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: HD SYNERGYUHD4 C-MOUNT CAMERA HEAD, AUT
• Device Catalogue Number: AR-3210-0021
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/21/2022
• Initial Report FDA Received Date: 06/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown