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

Model Number	NANOSCOPE HANDPIECE
Medical Device Problem Code	Fitting Problem (2183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/28/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported on 03/28/2022 by a facility representative via (b)(4) that an ar-3210-0040 obturator does not fit in the sheath.This occurred during a case with no patient harm.
Additional Manufacturer Narrative
The complaint is not confirmed.One unpackaged 761-0113-02 trocar and two 761-0126-02 obturators from an ar-3210-0040 were received for investigation.No nanoscope handpiece was returned.Functional testing identified that both trocars were able to be mated with the obturator.No problem found.

• 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: 19312930
• Report Number: 1220246-2024-03263
• Device Sequence Number: 14228669
• Product Code: GCJ
• UDI-Device Identifier: 00888867287839
• UDI-Public: 00888867287839
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K201134
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 05/14/2024

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: 01/31/2023
• Device Model Number: NANOSCOPE HANDPIECE
• Device Catalogue Number: AR-3210-0040
• Device Lot Number: 2106165
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/28/2022
• Initial Report FDA Received Date: 05/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2021
• 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