MAUDE Adverse Event Report: ARTHREX, INC. 4K LAPAROSCOPE, 0°, 5.5MM X 300MM

Model Number	4K LAPAROSCOPE, 0°, 5.5MM X 300MM
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/07/2025
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 08/07/2025, a facility representative reported via (b)(4) that an ar-3351-5500 scope had a detached lens.This was involved in a case where there was no patient harm.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.Damages caused by customer.Outer tube damaged, needle outer tube dent(s) deep dent outer tube bent.Outer tube damaged, distal tip damaged.Particulate, optics particulate under distal lens heavy residue particulate under proximal lens.Optical system, optical components optical system loose.Prism loose.Broken lenses in optical system.Cosmetic issue scratches/dents.See vendor evaluation.

• Brand Name: 4K LAPAROSCOPE, 0°, 5.5MM X 300MM
• 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: 22937889
• Report Number: 1220246-2025-03693
• Device Sequence Number: 15918843
• Product Code: GCJ
• UDI-Device Identifier: 00888867029774
• UDI-Public: (01)00888867029774(10)15026817
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: K941541
• 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): 12/12/2025

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, 0°, 5.5MM X 300MM
• Device Catalogue Number: AR-3351-5500
• Device Lot Number: 15026817
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 08/07/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/07/2025
• Supplement Date Received by Manufacturer: 12/10/2025
• Initial Report FDA Received Date: 09/02/2025
• Supplement Report FDA Received Date: 12/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown