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	09/14/2023
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
It was reported that during a demo peroneus recon surgery of the nanoneedle an image scattering in the form of horizontal lines on the nanoneedle monitor was noticed.There was no harm for patient, operator or third party reported.The surgery was finished with the same device anyway.It was not necessary to switch the surgical technique or do a second surgery.
Additional Manufacturer Narrative
(no problem found) the evaluation did not identify any issues relevant to the reported event.

• 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: 17919508
• Report Number: 1220246-2023-08154
• Device Sequence Number: 2893638
• Product Code: GCJ
• UDI-Device Identifier: 00888867375574
• UDI-Public: 00888867375574
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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
• Report Date (Section B): 08/01/2024

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: 09/30/2024
• Device Model Number: NANONEEDLE SCOPE, 125MM
• Device Catalogue Number: AR-3210-0043
• Device Lot Number: YS22010006
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/14/2023
• Supplement Date Received by Manufacturer: 07/03/2024
• Initial Report FDA Received Date: 10/12/2023
• Supplement Report FDA Received Date: 08/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2022
• 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