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	Insufficient Information (4580)
Date of Event	04/01/2021
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 contribution of the device to the reported event could not be determined as the device was not returned/received for evaluation.The most likely cause for the reported failure can be attributed to an eeprom failure.
Event or Problem Description
It was reported that the nanoscope has buttons that are not working properly.When pushed, the beeping sound occurs as expected but no image capture is initiated on the console.The case was completed by initiating image capture using the touchscreen on the nanoscope ccu.

• 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: 19391535
• Report Number: 1220246-2024-03841
• Device Sequence Number: 15150145
• Product Code: GCJ
• UDI-Device Identifier: 00888867287839
• UDI-Public: 00888867287839
• Combination Product (Y/N): N
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/24/2024

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: 2004111
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/13/2021
• Initial Report FDA Received Date: 05/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown