MAUDE Adverse Event Report: ARTHREX, INC. NANOSCOPIC RELEASE SYSTEM; LAPAROSCOPE

Model Number	NANOSCOPIC RELEASE SYSTEM
Medical Device Problem Code	No Display/Image (1183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/19/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On 6/24/2024, a sales representative reported via sems-(b)(4).That an ar-8850ds nanoscopic release system centerline with nanoneedle scope ectr system had no projected image once the scope was plugged into the console.The procedure was then aborted and not completed, and an open surgical procedure rather than nanoscopic was performed.This was discovered during a nanoscopic ctr procedure on (b)(6) 2024, with no reported patient harm.Additional information was received on 7/8/2024: the surgeon's decision to pivot to an open technique called an "open ctr" changed the surgical technique.A non-arthrex product was used for this technique.Due to the issue, no case delay was reported, and no adverse effects on the patient were reported.The patient did not require medical intervention or hospitalization, and no additional surgery was needed.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.(cable) this evaluation determined that the reported event occurred due to a failing cable.

• Brand Name: NANOSCOPIC RELEASE SYSTEM
• 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: 19792527
• Report Number: 1220246-2024-06839
• Device Sequence Number: 11811558
• Product Code: GCJ
• UDI-Device Identifier: 00888867390300
• UDI-Public: 00888867390300
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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): 02/27/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2025
• Device Model Number: NANOSCOPIC RELEASE SYSTEM
• Device Catalogue Number: AR-8850DS
• Device Lot Number: 3219134006
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/24/2024
• Supplement Date Received by Manufacturer: 12/17/2024
• Initial Report FDA Received Date: 07/22/2024
• Supplement Report FDA Received Date: 02/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2023
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown