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

Model Number	NANONEEDLE SCOPE, 125MM
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/17/2024
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 04/24/2024, it was reported by a sales representative via (b)(4) that an ar-3210-0043 nanoneedle scopes light source did not work.This occurred during a case on 04/17/2024.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.(device not returned) the most likely cause for the reported event is a failing light source.

• 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: jared engle ; 8009337001
• MDR Report Key: 19367132
• Report Number: 1220246-2024-03614
• Device Sequence Number: 6341621
• Product Code: GCJ
• UDI-Device Identifier: 00888867375574
• UDI-Public: 00888867375574
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 12/06/2024

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: NANONEEDLE SCOPE, 125MM
• Device Catalogue Number: AR-3210-0043
• Device Lot Number: 2206001
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/24/2024
• Supplement Date Received by Manufacturer: 11/11/2024
• Initial Report FDA Received Date: 05/21/2024
• Supplement Report FDA Received Date: 12/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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