MAUDE Adverse Event Report: ARTHREX, INC. 4K LAPAROSCOPE,30¿,5.5X300MM,HI-MAG, NIR

Model Number	4K LAPAROSCOPE,30¿,5.5X300MM,HI-MAG, NIR
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/24/2024
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 06/24/2024, it was reported by a facility representative via sems-06599319 that an ar-3352-5531 scope has a blurry lens.Case/patient involvement not indicated.
Additional Manufacturer Narrative
Vendor evaluation confirmed the reported condition.The device was damaged due to customer misuse.

• Brand Name: 4K LAPAROSCOPE,30¿,5.5X300MM,HI-MAG, NIR
• 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: 19781227
• Report Number: 1220246-2024-06816
• Device Sequence Number: 15461562
• Product Code: GCJ
• UDI-Device Identifier: 00888867346628
• UDI-Public: 00888867346628
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 02/06/2025

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 LAPAROSCOPE,30¿,5.5X300MM,HI-MAG, NIR
• Device Catalogue Number: AR-3352-5531
• Device Lot Number: 15147870
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/24/2024
• Supplement Date Received by Manufacturer: 01/15/2025
• Initial Report FDA Received Date: 07/19/2024
• Supplement Report FDA Received Date: 02/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown