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	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/14/2025
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 10/28/2025, a sales representative reported via (b)(4) that an ar-3352-5531 laparoscopes seal popped off.This was discovered after a case.Additional information was provided on 11/04/2025 via sems where it was reported that this was discovered at the end of a case before reprocessing.
Additional Manufacturer Narrative
The complaint allegation is confirmed based on photographic evidence of a ar-3352-5531, with a broken eyepiece seal.Based on the information provided ¿ which may include the returned device (if available), photographs, videos, event description, and any additional field input ¿ arthrex has determined the most likely cause.The most likely cause is attributed to user-related factors such as mechanical overstress due to repeated loading or off-axis insertion.

• 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: 23534081
• Report Number: 1220246-2025-05046
• Device Sequence Number: 9065534
• Product Code: GCJ
• UDI-Device Identifier: 00888867346628
• UDI-Public: (01)00888867346628(11)210414(10)13341771
• 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: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 03/03/2026

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: 13341771
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/28/2025
• Supplement Date Received by Manufacturer: 03/03/2026
• Initial Report FDA Received Date: 11/12/2025
• Supplement Report FDA Received Date: 03/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/14/2021
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown