MAUDE Adverse Event Report: Chess Medical Inc. NAJA; Gastrointestinal tube and accessories

Model Number	9A-03110
Medical Device Problem Codes	Difficult to Advance (2920); Positioning Problem (3009)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	08/24/2026
Type of Reportable Event	Serious Injury

• Brand Name: NAJA
• Common Device Name: Gastrointestinal tube and accessories
• Manufacturer (Section D): Chess Medical Inc.; 1010 sainte-catherine quest; 3rd floor suite 3-115; montreal QC H3B 5 L1; CA H3B 5L1
• Manufacturer (Section G): Chess Medical Inc.; 1010 sainte-catherine quest; 3rd floor suite 3-115; montreal QC H4E 1 A2; CA H4E 1A2
• Manufacturer Contact: christina lam ; 300 boston scientific way; marlborough, MA 01752 ; +1(914)571-6918
• MDR Report Key: 50874511
• Report Number: 3005099803-2026-03923
• Device Sequence Number: 15808863
• Product Code: FGD
• UDI-Device Identifier: 00191506060985
• UDI-Public: (01)00191506060985(17)271201(10)1602455
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K223890
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/23/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 9A-03110
• Device Catalogue Number: 9A-03110
• Device Lot Number: 0001602455
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/28/2026
• Initial Report FDA Received Date: 09/23/2026
• Date Device Manufactured: 12/11/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown