Pillcam FGS-0110Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07290101360636), received between Mar 14, 2019 and Nov 12, 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.

• InjuryNov 12, 2019Entrapment of Device; Entrapment of Device

  ACCORDING TO THE REPORTER, THEY HAD A PATIENT THAT SWALLOWED A PATENCY CAPSULE AND THE CAPSULE CAUSED A PERFORATION WHICH RESULTED IN THE PATIENT NEEDING EMERGENCY SURGERY FOR REMOVAL. AFTER 36 HOURS OF SWALLOWING THE PATENCY CAPSULE, IT WAS STILL IN FULL FORM. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Perforation

  MAUDE report 9313320 ↗
• InjuryMar 14, 2019Entrapment of Device; Entrapment of Device

  ACCORDING TO THE REPORTER, THEY HAD A RETAINED CAPSULE. THE KUB (KIDNEY, URETER, BLADDER) X-RAY DONE SHOWED THAT THE PREVIOUSLY NOTED RECTANGULAR RADIODENSITY WAS NOW APPARENT AT THE LEFT ASPECT OF THE ABDOMEN/UPPER PELVIS, AT THE LEVEL OF THE PELVIC BRIM, PROBABLY IN THE DESCENDING COLON. IT WAS ASSUMED THAT THE PATIENT PASSED THE CAPSULE. THE PATIENT REPORTED DAILY BOWEL MOVEMENT WITH NO ABDOMINAL PAIN. THE LAST KNOWN PATIENT STATUS WAS DOING WELL.

  Patient problems: Radiation Exposure, Unintended

  MAUDE report 8422999 ↗