PillCam FGS-0320Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07290101361404), received between Jan 9, 2019 and Feb 8, 2019 — classified as 2 injuries.

The most frequently reported specific device problem is “Entrapment of Device” (2 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 8, 2019Entrapment of Device; Entrapment of Device

  ACCORDING TO LITERATURE SOURCE OF STUDY PERFORMED, 30 MINUTES AFTER INGESTION OF THE CAPSULE, THE REAL-TIME VIEWER SUGGESTED THAT THE LOCATION WAS IN THE PATIENT'S OROPHARYNX. AFTER 30 MINUTES OF INSPECTION, IT WAS INDICATED THAT THE RETENTION WAS IN THE PHARYNGEAL TRACT OF THE PATIENT. THE CAPSULE LOCATION WAS VIEWED VIA GASTROSCOPY AND WAS PLACED ENDOSCOPICALLY IN THE DUODENUM. NO REPEAT PROCEDURE WAS NEEDED. THERE WAS NO FURTHER INJURY TO THE PATIENT.

  Patient problems: Aspiration/Inhalation

  MAUDE report 8320012 ↗
• InjuryJan 9, 2019Entrapment of Device; Entrapment of Device

  ACCORDING TO THE REPORTER, PATIENTS WITH KNOWN OR SUSPECTED CROHN¿S DISEASE (CD) UNDERWENT COMPLETE EXAMINATION FOR AN EVALUATION OF THE SMALL BOWEL. THERE WAS ONE CASE OF STOMACH RETENTION OF THE CAPSULE, WHICH OCCURRED DESPITE HAVING A PATENCY CHECK. A FOLLOW-UP PLAIN ABDOMINAL X-RAY WAS PERFORMED, AND THE PATENCY CAPSULE HAD BEEN REPORTED TO BE IN THE LARGE BOWEL. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8232133 ↗