MAUDE Adverse Event Report: ARTHREX, INC. NANOSCOPE HANDPIECE; LAPAROSCOPE

Model Number	NANOSCOPE HANDPIECE
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Arthritis (1723); Syncope/Fainting (4411)
Date of Event	03/18/2022
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
It was reported that during a knee nanoneedle study one patient had a vasovagal reaction during/after the intervention.No further information was provided.
Additional Manufacturer Narrative
Additional information: b3, b5, h3, h6.
Event or Problem Description
Update avoe 21-mar-2025.It was further reported that the incident occurred on the (b)(6) 2022 and the patient had a vasovagal reaction, directly after the procedure.The patient was treated with a drainage of a bacterial knee arthritis under local anesthesia.
Additional Manufacturer Narrative
Additional information: d1, d2a, d2b, d4, d9, g3, g4, h3, h6.Device not returned.The most likely cause for the reported event is a sharp or rough edge on the scope.

• 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: 21062316
• Report Number: 1220246-2025-09182
• Device Sequence Number: 8153719
• Product Code: GCJ
• UDI-Device Identifier: 00888867287839
• UDI-Public: (01)00888867287839(11)220401(17)230930(10)2106177
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K201134
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/01/2025

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 Model Number: NANOSCOPE HANDPIECE
• Device Catalogue Number: AR-3210-0040
• Device Lot Number: 2106177
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/06/2024
• Supplement Date Received by Manufacturer: Not provided; 04/18/2025
• Initial Report FDA Received Date: 01/02/2025
• Supplement Report FDA Received Date: 04/10/2025; 05/01/2025
• 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