MAUDE Adverse Event Report: ARTHREX, INC. NANOSCOPE CONSOLE; LAPAROSCOPE

Model Number	NANOSCOPE CONSOLE
Medical Device Problem Code	No Display/Image (1183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/25/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
It was reported that, during a wrist arthroscopy, the screen of the device stopped working.There was power to the device, and the screen was ¿on¿; however, the screen was blank.It was tried to turn the device off and on (hard reset etc.) but nothing worked.According to the surgeon, no harm for patient, operator or third party occurred.The surgery was finished successfully with a different device (they had to switch to using their smith and nephew camera stack and a 2.7mm scope.).It was not necessary to switch the surgical technique or do a second surgery.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.(som) this evaluation determined that the reported event occurred due to a failing som.

• Brand Name: NANOSCOPE CONSOLE
• 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: 19750280
• Report Number: 1220246-2024-06765
• Device Sequence Number: 20466034
• Product Code: GCJ
• UDI-Device Identifier: 00888867299580
• UDI-Public: 00888867299580
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K201134
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/20/2025

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 Model Number: NANOSCOPE CONSOLE
• Device Catalogue Number: AR-3200-0030
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/25/2024
• Supplement Date Received by Manufacturer: 12/11/2024
• Initial Report FDA Received Date: 07/16/2024
• Supplement Report FDA Received Date: 01/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/09/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown