PillCam FGS-0662Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07290110360559), received between Jun 14, 2019 and Jun 20, 2019 — classified as 2 injuries.

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

• InjuryJun 20, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, THE PATIENT COMPLAINED OF NAUSEA, VOMITING AND ABDOMINAL PAIN FOR 2 DAYS AND WENT TO THE EMERGENCY ROOM. THE ADVERSE EVENTS OCCURRED WITHIN 4 DAYS POST CAPSULE PROCEDURE, PRECEDED BY BOWEL PREP. THE PATIENT HAD 2 DAYS EXTEND HOSPITALIZATION. A COMPUTED TOMOGRAPHY (CT) ABDOMEN REVEALED CAPSULE WAS IN THE LARGE BOWEL AND NO EVIDENCE OF SMALL BOWEL OBSTRUCTION. THE CAPSULE SITED ON CT 4 DAYS POST INDEX PROCEDURE AND NOT CONSIDERED A CAPSULE RETENTION. EXACERBATION OF CROHN'S DISEASE, HOWEVER POSSIBLE RELATEDNESS TO CAPSULE ONLY DUE TO CAPSULE WAS SEEN IN THE LARGE BOWEL, BUT THE PATIENT PASSED THE CAPSULE NATURALLY. NO REPEAT PROCEDURE WAS NEEDED.

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

  MAUDE report 8716327 ↗
• InjuryJun 14, 2019Entrapment of Device; Entrapment of Device

  ACCORDING TO THE REPORTER, THEY HAD A RETAINED CAPSULE IN THE COLON BEYOND THE EXPECTED 14 DAYS. TWO SEPARATE X-RAYS PERFORMED ON A DIFFERENT DAY TO CONFIRM THE ISSUE. PERFORMED TO DETERMINE CAPSULE RETENTION AND TO DETERMINE IF CAPSULE WAS STILL IN THE COLON OR HAD BEEN EXCRETED. THE CAPSULE WAS REMOVED ENDOSCOPICALLY FROM TERMINAL ILEUM AFTER DILATION OF ILEOCOLONIC ANASTOMOSIS. THE PATIENT WAS PREPPED FOR THE PROCEDURE AND WAS NOT UNDER ANESTHESIA. A REPEAT PROCEDURE WAS NOT NEEDED.

  Patient problems: Radiation Exposure, Unintended

  MAUDE report 8699431 ↗