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

Model Number	4K SYNERGYID CAMERA HEAD, AUTOCLAVABLE
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/25/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that device is overheating.There was no harm for the patient, operator or third party reported.No further information received.
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.The reported event was not confirmed.The service evaluation revealed a broken grabber mount but no other damages or malfunction had been observed.

• Brand Name: 4K SYNERGYID CAMERA HEAD, AUTOCLAVABLE
• 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: 19055834
• Report Number: 1220246-2024-01850
• Device Sequence Number: 8167609
• Product Code: GCJ
• UDI-Device Identifier: 00888867348844
• UDI-Public: 00888867348844
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K202582
• 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): 04/05/2024

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: 4K SYNERGYID CAMERA HEAD, AUTOCLAVABLE
• Device Catalogue Number: AR-3210-0033
• Device Lot Number: 11562722
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/27/2020
• 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