MAUDE Adverse Event Report: ARTHREX, INC. NANONEEDLE SCOPE, 180MM; LAPAROSCOPE

Model Number	NANONEEDLE SCOPE, 180MM
Medical Device Problem Code	Key or Button Unresponsive/not Working (4063)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/14/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an arthroscopy on the right knee different issues with the console have occurred.White sporadic flashes were visible on the camera image.The camera button of the nano needle did not work.No images were visible on the tablet.( black image and no export to usb or ipad was possible for a specific case) and the headup display could not be activated.There was no harm for patient, operator or third party reported.The surgery was finished successfully with the same device anyway.It was not necessary to switch the surgical technique or do a second surgery.
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
Additional information: g3, h3, h6.Based on the information provided which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex was able to conclude a most likely cause.The most likely cause for the reported failure can be attributed to user error of the device due to improper cleaning process used - thus causing moisture intrusion.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.Based on the information provided ¿ which may include the returned device (if available), photographs, videos, event description, and any additional field input ¿ arthrex has determined the most likely cause.The reported failure is most likely due to a supplier or manufacturing issue, resulting in the loss of image display and control functionality during arthroscopy.

• Brand Name: NANONEEDLE SCOPE, 180MM
• 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: 19512377
• Report Number: 1220246-2024-05572
• Device Sequence Number: 20696029
• Product Code: GCJ
• UDI-Device Identifier: 00888867375567
• UDI-Public: 00888867375567
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K201134
• 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,Followup
• Report Date (Section B): 12/09/2025

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 Expiration Date: 12/31/2024
• Device Model Number: NANONEEDLE SCOPE, 180MM
• Device Catalogue Number: AR-3210-0044
• Device Lot Number: YS23001006
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/16/2024
• Supplement Date Received by Manufacturer: 12/18/2024; 11/21/2025
• Initial Report FDA Received Date: 06/11/2024
• Supplement Report FDA Received Date: 01/14/2025; 12/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/01/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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