MAUDE Adverse Event Report: Arthrex, Inc. NanoScopic Release System; LAPAROSCOPE

Model Number	NanoScopic Release System
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/25/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that prior to the minimally invasive carpal tunnel release surgery, it was determined that the nanoneedle scope could not be passed down the nanoscopic release system centerline.As a result, the planned surgical technique had to be changed, and the patient underwent open surgery instead.The surgery was finished successfully.It was not necessary to do a second surgery.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.

• Brand Name: NanoScopic Release System
• Common Device Name: LAPAROSCOPE
• Manufacturer (Section D): Arthrex, Inc.; 1370 creekside boulevard; naples FL 34108 -194
• Manufacturer (Section G): Arthrex, Inc.; 1370 creekside boulevard; naples FL 34108 -194
• Manufacturer Contact: jared engle ; +1(800)933-7001
• MDR Report Key: 50689066
• Report Number: 1220246-2026-04629
• Device Sequence Number: 17462747
• Product Code: GCJ
• UDI-Device Identifier: 00888867390300
• UDI-Public: 00888867390300
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K243008
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 09/09/2026

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 Model Number: NanoScopic Release System
• Device Catalogue Number: AR-8850DS
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/25/2026
• Initial Report FDA Received Date: 09/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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