PillCam FGS-0517Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 07290101364788), received between Apr 18, 2019 and Oct 25, 2024 — classified as 5 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Entrapment of Device” (3 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryOct 25, 2024Entrapment of Device; Entrapment of Device

  ACCORDING TO THE REPORTER, THE PATIENT HAD A RETAINED CAPSULE IN THEIR SMALL BOWEL SINCE (B)(6) 2024 AND BELIEVE THAT IT WAS STUCK PROXIMAL TO A SEGMENT OF INFLAMED CROHN'S. THE PATIENT WAS ASYMPTOMATIC AND HAD NO COMPLICATIONS BUT ALREADY HAD 3 LAPAROTOMIES SO FURTHER SURGERY WOULD HAVE SIGNIFICANT RISK. TRIED TO HAVE SOME STEROIDS TO SEE IF THIS MAKES A DIFFERENCE.

  Patient problems: Foreign Body In Patient

  MAUDE report 20532481 ↗
• MalfunctionJul 12, 2024Material Fragmentation; Material Fragmentation

  ACCORDING TO THE REPORTER, THE VITREOUS DOME WAS DETACHED FROM THE CAPSULE. THE PATIENT RETRIEVED THE CAPSULE INTO THE BOWL WHEN EXPELLING AND IT WAS INTO TWO PIECES. THE PATIENT WAS STRESSED AND WORRIED ABOUT KNOWING WHAT THE OPEN CAPSULE MIGHT CAUSED HER COLON. THERE WAS NO X-RAY PERFORMED TO THE PATIENT. THERE WAS NO PATIENT AND USER HARM.

  Patient problems: Anxiety

  MAUDE report 19736028 ↗
• InjuryAug 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, APPROXIMATELY 15 MINUTES AFTER THE PATIENT SWALLOWED THE CAPSULE, THE RECORDER STOPPED FLASHING BLUE LIGHT. HIGH ENDOSCOPY WAS PERFORMED TO RETRIEVE THE CAPSULE FROM THE PATIENT'S STOMACH WITH THE LEDS OFF. ANOTHER CAPSULE WAS USED TO PERFORM THE PROCEDURE WITHOUT AN ISSUE.

  Patient problems: Foreign Body In Patient; Insufficient Information

  MAUDE report 15259669 ↗
• InjuryAug 12, 2021Entrapment of Device; Entrapment of Device

  ACCORDING TO THE REPORTER, THE PATIENT WAS ADMITTED INTO EMERGENCY WITH CAPSULE RETENTION AND WAS EXPERIENCING SYMPTOMS OF NAUSEA AND ABDOMINAL PAIN. THE RETENTION WAS IN THE SMALL BOWEL. THE SMALL BOWEL OBSTRUCTION WAS POSSIBLY COMPLICATED BY PERFORATION. THE PATIENT HAD A CT SCAN LAST MONTH WHICH WAS NORMAL BUT SHOWED BILATERAL INGUINAL HERNIAS CONTAINING BOWEL. HOWEVER IT DID NOT LOOK AS IF THE CAPSULE WAS IN THE GROIN. THE RETENTION WAS DUE TO PATIENT PATHOLOGY NOT EQUIPMENT OR CAPSULE FAILURE. THE PATIENT WAS STILL IN HOSPITAL AT THE TIME OF REPORT.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 12315405 ↗
• InjuryAug 17, 2020Unintended Application Program Shut Down; Unintended Application Program Shut Down

  ACCORDING TO THE REPORTER, THE PATIENT WAS HOSPITALIZED FOR DARK BLEEDING. DURING HOSPITALIZATION, THE PATIENT UNDERWENT AN ENTEROSCOPY EXAM TO VIEW THE SMALL INTESTINE USING A VIDEO CAPSULE. AFTER THE VIDEO WAS DOWNLOADED, IT WAS OBSERVED THAT THERE WAS ONLY 2 MINUTES OF VIDEO IN THE STOMACH AND THEN THE VIDEO "STARTED JUST 4 HOURS LATER". THE CAPSULE WAS ALREADY IN THE INTESTINE SLENDER. THE INITIAL SEGMENT OF THE SMALL INTESTINE WAS NOT SEEN. THE PATIENT REMAINED IN THE HOSPITAL 2 DAYS TO ENSURE THAT THE PATIENT WAS NOT BLEEDING AND ALSO TO PERFORM A NEW EXAMINATION. AS PER CUSTOMER THEY HAVE FOLLOWED THE PROCEDURES NORMALLY, HOWEVER THE DOCTOR DOES NOT REMEMBER HAVING "DELAYED THE FIRST INSTRUCTION".

  Patient problems: No Code Available

  MAUDE report 10414312 ↗
• InjuryOct 8, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, THE PATIENT FELT THAT THEY WERE DEHYDRATED AND VOMITED. THE PATIENT DECIDED TO GO TO THE EMERGENCY ROOM AND WAS TREATED WITH IV (INTRAVENOUS) FLUIDS AND WITH A MEDICATION PRAMIN. THE PATIENT WAS DISCHARGED AFTER 4 HOURS IN GOOD GENERAL CONDITION. THE PATIENT WAS PREPPED FOR THE PROCEDURE AND WAS NOT UNDER ANESTHESIA. A REPEAT PROCEDURE WAS NOT NECESSARY.

  Patient problems: Dehydration; Vomiting

  MAUDE report 9166106 ↗
• MalfunctionApr 18, 2019Entrapment of Device; Entrapment of Device

  ACCORDING TO THE REPORTER, DURING USE, THEY WERE UNABLE TO ASSESS THE PATIENT AS THE CAPSULE GOT STUCK IN THE CECUM. IT WAS UNCERTAIN WHEN THE CAPSULE LEFT THE CECUM, SINCE THE CAPSULE BATTERY LASTED ONLY FOR 10 HOURS, BUT IT WAS REPORTED THAT THE CAPSULE EXITED THE BODY WITHOUT ANY INTERVENTIONS. THERE WAS NO PATIENT OR USER HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8527286 ↗