PillCam FGS-0179Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07290101360575), received between May 14, 2021 and May 14, 2021 — classified as 1 injury.

The most frequently reported specific device problem is “Entrapment of Device” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryMay 14, 2021Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT THE PATIENT UNDERGONE PILLCAM STUDY SUCCESSFULLY ON (B)(6) 2016 WHEN THE PATIENT WAS 4 YEARS OF AGE AND REPORTED THAT THE CAPSULE HAD NOT LEFT THE SMALL BOWEL AFTER 8 HOURS OF STUDY. THE PATIENT HAD NO SYMPTOMS OF OBSTRUCTION OR ANY SYMPTOMS RELATED TO THE FOREIGN BODIES. ON (B)(6) 2021, THE FACILITY IDENTIFIED THAT THE PILLCAM WAS STILL IN THE PATIENT STUCK TO A COIN IN THEIR SMALL BOWEL. THE PATIENT WAS A CROHN¿S DISEASE PATIENT UNDERGOING AN MRE TO EVALUATE HER DISEASE AND THE OBJECTS WEREFOUND ON SCOUT FILM PRIOR TO MRE. IT WAS THOUGHT THAT THE PILLCAM HAD BROKEN APART. THE COIN AND THE FRAGMENTS THOUGHT TO BE PILLCAM WERE STUCK TOGETHER WHEN FOUND. A SURGERY WAS PERFORMED TO REMOVE THE FOREIGN BODY. UPON REMOVAL OF THE PILLCAM, IT WAS NOTED THAT THE PATIENT HAD SMALL BOWEL ADHESIONS, THE SURGEON STATED THAT IT MOST LIKELY TO BE SECONDARY TO NEC THE PATIENT HAD AS AN INFANT (THE PATIENT WAS A PREMATURE INFANT). IT WAS A MID-SMALL BOWEL SO IT WAS ALSO REMOVED VIA OPEN SURGERY. THE ORGANS SURROUNDING THE FOREIGN BODY WERE UNAFFECTED AND THE PATIENT CONDITION IS STABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 11827463 ↗