MAUDE Adverse Event Report: ARTHREX, INC. 4K CMT PANO ARTHROSCOPE,45°,4.2MM X161MM; LAPAROSCOPE

Model Number	4K CMT PANO ARTHROSCOPE,45°,4.2MM X161MM
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/05/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On 06/05/2024 it was reported by a sales representative via (b)(4) that an ar-3355-4050 scope stopped working during a case.Discovered during case with no patient harm.
Additional Manufacturer Narrative
The complaint allegation is confirmed.One unpackaged ar-3355-4050 serial/batch number (b)(6) was received for evaluation.Visual evaluation revealed that the sheath had striation marks along it.The perimeter of the distal end was also nicked.Additionally, the lens had damage and black spots on it.Functional testing could not be performed due to the lack of testing equipment.However, due to the various signs of external damage, it can be deduced that the device did not function as required as stated in the complaint allegation.The most likely cause is attributed to misuse due to prying/leveraging the device during use.Dfu-0399-eo revision 1 recommends the following regarding proper care: regular and proper maintenance of your synergy vision ccu and / or camera heads are the best ways to protect your investment and avoid non-warranty repairs.Recommended care and handling of the synergy vision ccu and camera heads includes proper day-to-day operation, cleaning, and sterilization which are extremely important to ensure safe and efficient operation.It is important to visually inspect the camera head, cable, and card edge before each use.

• Brand Name: 4K CMT PANO ARTHROSCOPE,45°,4.2MM X161MM
• 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: 19665420
• Report Number: 1220246-2024-06564
• Device Sequence Number: 6595882
• Product Code: GCJ
• UDI-Device Identifier: 00888867405851
• UDI-Public: 00888867405851
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K233451
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/20/2025

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: 4K CMT PANO ARTHROSCOPE,45°,4.2MM X161MM
• Device Catalogue Number: AR-3355-4050
• Device Lot Number: 15187881
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/05/2024
• Supplement Date Received by Manufacturer: 12/26/2024
• Initial Report FDA Received Date: 07/03/2024
• Supplement Report FDA Received Date: 01/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/29/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown