MAUDE Adverse Event Report: AnX Robotica Corp. NaviCam; NaviCam SB Capsule

Catalog Number	CP-US-7001
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Airway Obstruction (1699)
Date of Event	09/02/2026
Type of Reportable Event	Serious Injury

• Brand Name: NaviCam
• Common Device Name: NaviCam SB Capsule
• Manufacturer (Section D): AnX Robotica Corp.; 6010 w spring creek parkway; plano TX 75024
• Manufacturer (Section G): Ankon Tehcnologies Co Ltd; b3-2, d3-4, biolake, no.666; hi-tech road, east lake ntd; wuhan CN
• Manufacturer Contact: tim thomas ; 6010 w spring creek parkway; plano, TX 75024 ; +1(770)480-2911
• MDR Report Key: 50908459
• Report Number: 3016544248-2026-00002
• Device Sequence Number: 17655669
• Product Code: NEZ
• UDI-Device Identifier: 00810164590008
• UDI-Public: 00810164590008
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K233229
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse Practitioner
• Type of Report: Initial
• Report Date (Section B): 09/25/2026

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: CP-US-7001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 09/02/2026
• Initial Report FDA Received Date: 09/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Other; Required Intervention; Hospitalization
• Patient Sex: Male