PillCam FGS-0661Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07290110360542), received between Feb 27, 2019 and Feb 27, 2019 — 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.

• InjuryFeb 27, 2019Entrapment of Device; Entrapment of Device

  ACCORDING TO THE REPORTER, THE PATIENT INGESTED A CAPSULE, BUT IT WAS NOT EXPELLED YET. THEY PERFORMED A KIDNEY, URETER, AND BLADDER (KUB) X-RAY AND IT SHOWED THAT THE CAPSULE WAS IN THE CENTRAL PELVIS. THE COLONOSCOPY NOTED A BENIGN STRICTURING AT ILEOCECAL VALVE WHICH WAS DILATED WITH A BALLOON CATHETER, BUT THE CAPSULE WAS NOT SEEN. THE PATIENT HAD AN ABDOMINAL PAIN, EXPERIENCED VOMITING, AND HAD AN ELEVATED WHITE BLOOD CELLS. THE PATIENT WAS ADMITTED AND A REPEAT CT SCAN SHOWED MILD BOWEL DILATATION MEASURING UP TO 3.1 CENTIMETERS AND THE CAPSULE WAS SEEN RESULTING IN OBSTRUCTION. THE CAPSULE WAS REMOVED VIA COLONOSCOPY. THE PATIENT WAS GIVEN STEROIDS TO DECREASE INFLAMMATION AND WAS DOING WELL WITH NO COMPLICATIONS.

  Patient problems: Abdominal Pain; Inflammation; Radiation Exposure, Unintended; Vomiting

  MAUDE report 8375127 ↗