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

Model Number	NANOSCOPE CONSOLE
Medical Device Problem Code	Failure to Charge (1085)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/12/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On 6/14/2024, it was reported by an arthrex employee via (b)(4) that an ar-3200-0030 nanoscope console (from a loaner set rar-3200-0030 / sn: (b)(6) would not hold a charge and will only work if plugged in.The case was completed with the ar-3200-0030 nanoscope console being plugged in through the entire procedure.This was discovered during an in/off carpal tunnel release procedure (b)(6) 2024 , with no reported patient harm.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
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 wear and tear.The manufacturing date is 2019.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.This evaluation determined that the reported event was caused by failing batteries or battery chips due to wear and tear.

• 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: 19709546
• Report Number: 1220246-2024-06676
• Device Sequence Number: 3116137
• Product Code: GCJ
• UDI-Device Identifier: 00888867299580
• UDI-Public: 00888867299580
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K201134
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/23/2025

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
• Device Lot Number: 201941
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/14/2024
• Supplement Date Received by Manufacturer: 12/18/2024; 04/18/2025
• Initial Report FDA Received Date: 07/10/2024
• Supplement Report FDA Received Date: 01/14/2025; 04/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/15/2019
• 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