MAUDE Adverse Event Report: ARTHREX, INC. NANONEEDLE SCOPE, 125MM; LAPAROSCOPE

Model Number	NANONEEDLE SCOPE, 125MM
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/19/2023
Type of Reportable Event	Malfunction
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.
Event or Problem Description
On 7/20/2023, it was reported by a sales representative via sems that an ar-3210-0043 nanoneedle scope and an ar-3210-0041 nanoscope operative high-flow sheath kit had an issue.The visual quality and light source output was not sufficient to adequately see.To troubleshoot, the nano was recalibrated twice and plugged the console into different power sources and the issue was not resolved.The case was completed by opening a traditional 2.7mm scope.This was discovered during an subtalar arthroscopy procedure on (b)(6) 2023, with no patient harm.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.(led) this evaluation determined that the reported event most likely occurred due to a failing led.

• Brand Name: NANONEEDLE SCOPE, 125MM
• 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: emily shafer ; 8009337001
• MDR Report Key: 17572567
• Report Number: 1220246-2023-07547
• Device Sequence Number: 15509550
• Product Code: GCJ
• UDI-Device Identifier: 00888867375574
• UDI-Public: 00888867375574
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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
• Report Date (Section B): 11/04/2024

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 Expiration Date: 08/31/2024
• Device Model Number: NANONEEDLE SCOPE, 125MM
• Device Catalogue Number: AR-3210-0043
• Device Lot Number: YS22090002
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/20/2023
• Supplement Date Received by Manufacturer: 05/13/2024
• Initial Report FDA Received Date: 08/18/2023
• Supplement Report FDA Received Date: 11/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2022
• 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