MAUDE Adverse Event Report: ARTHREX, INC. 4K LAPAROSCOPE, 30¿, 10X330MM, NIR

Model Number	4K LAPAROSCOPE, 30¿, 10X330MM, NIR
Medical Device Problem Code	Poor Quality Image (1408)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/18/2024
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 06/18/2024 it was reported by a facility representative via (b)(4) that an ar-3351-1031 scope has an inability to effectively focus the image.Case/patient involvement not indicated.
Additional Manufacturer Narrative
The complaint allegation is confirmed.One unpackaged ar-3351-1031 serial/batch number (b)(6) was received for evaluation.Visual evaluation revealed that the sheath had deep striation marks along it.The perimeter of the distal end was also nicked.Additionally, the lens had a crack across it, which is likely related to the complaint allegation.Functional testing could not be performed due to the damage of the lens.The most likely cause is attributed to misuse due to prying/leveraging the device during use.Dfu-0327-eo revision 0 provides helpful information on maintaining the integrity of the lens: do not subject the endoscope to impact.Put the endoscope down carefully.Hold the endoscope only by the ocular funnel/main part and not by the sheath.Do not bend the sheath or use as a prying tool.

• Brand Name: 4K LAPAROSCOPE, 30¿, 10X330MM, 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: 19718862
• Report Number: 1220246-2024-06688
• Device Sequence Number: 18211391
• Product Code: GCJ
• UDI-Device Identifier: 00888867161122
• UDI-Public: 00888867161122
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 01/20/2025

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 LAPAROSCOPE, 30¿, 10X330MM, NIR
• Device Catalogue Number: AR-3351-1031
• Device Lot Number: 12228789
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/18/2024
• Supplement Date Received by Manufacturer: 12/26/2024
• Initial Report FDA Received Date: 07/11/2024
• Supplement Report FDA Received Date: 01/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/03/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown