MAUDE Adverse Event Report: ARTHREX, INC. ENDOSCOPE, 0°, 4 MM X 174 MM, HD; ARTHROSCOPE AND ACCESSORIES

Model Number	ENDOSCOPE, 0°, 4 MM X 174 MM, HD
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/20/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device has not yet been evaluated.The investigation is in progress.When the device evaluation becomes available, a follow-up report will be submitted.
Event or Problem Description
On 05/20/2024, it was reported by a facility representative via (b)(4) that an ar-3000aw scope is overheating.This occurred during use in a case with no patient impact.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.The complaint allegation is confirmed.One unpackaged ar-3000aw serial/batch number (b)(6) was received for evaluation.Functional testing could not be conducted because of the lack of a mating part.A visual inspection revealed damage at the distal end of the tip-signs of wear and tear.The most likely reason for the reported failure is the wear and tear damage incurred over repeated usage.The device was manufactured in 2021.

• Brand Name: ENDOSCOPE, 0°, 4 MM X 174 MM, HD
• Common Device Name: ARTHROSCOPE AND ACCESSORIES
• 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: 19546860
• Report Number: 1220246-2024-05860
• Device Sequence Number: 6711844
• Product Code: HRX
• UDI-Device Identifier: 00888867028302
• UDI-Public: 00888867028302
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/21/2025

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 Model Number: ENDOSCOPE, 0°, 4 MM X 174 MM, HD
• Device Catalogue Number: AR-3000AW
• Device Lot Number: 14093825
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2024
• Supplement Date Received by Manufacturer: 12/26/2024
• Initial Report FDA Received Date: 06/17/2024
• Supplement Report FDA Received Date: 01/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown