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

Model Number	NANOSCOPE HANDPIECE
Medical Device Problem Code	No Display/Image (1183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/25/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This 3500a record is submitted to comply with an fda 483 inspectional observation issued to arthrex inc on may 5, 2023.Arthrex has reassessed the reportability decisions made on historical complaint records using revised criterion.This 3500a document is a result of the reassessment.The complaint is confirmed based on the customer provided video, which shows that the nanoscope had issue with the image.The most likely cause of this failure is attributed to wear and tear damage incurred over repeated usage.
Event or Problem Description
It was reported that during an elbow arthroscopy & debridement surgery after the first half of the procedure went as expected the image was unexpectedly lost.The shaver had just entered the joint, but there was no contact and/or damage to the nanoscope sheath/camera itself.The device intermittently flashed and gave a screen/image with grey stripes on the monitor.A second nanoscope was opened and connected.The system wanted to go through a full reboot but then the handpiece did not work.Therefore a third nanoscope was opened and the surgeon was able to finish the surgery successfully with the third one.There was no harm for patient, operator or third party reported.It was not necessary to switch the surgical technique or do a second surgery.

• Brand Name: NANOSCOPE HANDPIECE
• 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: 19537107
• Report Number: 1220246-2024-05777
• Device Sequence Number: 12368512
• Product Code: GCJ
• UDI-Device Identifier: 00888867287839
• UDI-Public: 00888867287839
• 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
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 06/14/2024

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: 04/30/2022
• Device Model Number: NANOSCOPE HANDPIECE
• Device Catalogue Number: AR-3210-0040
• Device Lot Number: 2004110
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/03/2021
• Initial Report FDA Received Date: 06/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2020
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown