MAUDE Adverse Event Report: ANX ROBOTICA CORP NAVICAM SB CAPSULE; CAPSULE ENDOSCOPY

Catalog Number	CP-US-700100810164590008
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aspiration/Inhalation (1725)
Date of Event	05/08/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient underwent routine video capsule endoscopy ofr evaluation of unexplained iron deficiency anemia.Prior upper endoscopy and colonoscopy had demonstrated a hiatal hernia, however, no esophageal obstruction had previously been identified.Afer swallowing the capsule, the patient immediately experienced a choking sensation and chest discomfort.Despite drinking clear water, the capsule remained lodged in the esophagus for approximately 2-3 hours.Imaging confirmed that the capsule had not progressed beyond the esophagus.Because the capsule failed to pass spontaneously, the patient was transferred to the surgical center for urgent upper endoscopy.

• Brand Name: NAVICAM SB CAPSULE
• Common Device Name: CAPSULE ENDOSCOPY
• Manufacturer (Section D): ANX ROBOTICA CORP; 6010 w spring creek parkway; plano TX 75024
• Manufacturer (Section G): ANKON TECHNOLOGIES; d3-4 biolake no 666 hi-tech ro; east lake new tech zdev zone; wuhan, china 43007 5; CH 430075
• Manufacturer Contact: tim thomas ; 6010 w spring creek parkway; plano, TX 75024 ; 7704892911
• MDR Report Key: 25449436
• Report Number: 3016544248-2026-00001
• Device Sequence Number: 17602266
• Product Code: NEZ
• UDI-Device Identifier: 00810164590008
• UDI-Public: 00810164590008
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K233229
• Exemption Number: 00001
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 06/09/2026

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-700100810164590008
• 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: 05/08/2026
• Initial Report FDA Received Date: 06/09/2026
• 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: Required Intervention
• Patient Age: 64 YR
• Patient Sex: Unknown