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

Model Number	NANO NEEDLE SCOPE, 125MM
Medical Device Problem Code	Failure to Calibrate (2440)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/06/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On 2/6/2023 it was reported by a sales representative via sems that an ar-3210-0043 nanoneedle was displaying an error message.The error message had a red x on the console and said "unable to calibrate.Try again." this was discovered during a procedure and was completed with another nanoneedle with no patient harm.
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 device was not received for evaluation.Based off the information provided, the most likely cause for the reported failure can be attributed to a failing headboard.

• Brand Name: NANO NEEDLE 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: jared engle ; 8009337001
• MDR Report Key: 19540594
• Report Number: 1220246-2024-05828
• Device Sequence Number: 7575025
• Product Code: GCJ
• UDI-Device Identifier: 00888867375574
• UDI-Public: 00888867375574
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• 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: 05/31/2024
• Device Model Number: NANO NEEDLE SCOPE, 125MM
• Device Catalogue Number: AR-3210-0043
• Device Lot Number: 2205006
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/06/2023
• Initial Report FDA Received Date: 06/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown