Pillcam FGS-0347Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 07290101362951), received between Sep 7, 2018 and Apr 14, 2026 — classified as 1 death, 5 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Unintended Application Program Shut Down” (4 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 14, 2026Overheating of Device; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE RECORDER BECAME WARM WHEN IT STOPPED WORKING BEFORE 9 PM. THE PATIENT WAS JUST SITTING WHEN THE INCIDENT OCCURRED AND THE PATIENT DID NOT SUSTAIN A BURN. THE STUDY WAS COMPLETED IN 10 HOURS. THERE WAS NO PATIENT OR USER HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24872834 ↗
• DeathJul 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, THE PATIENT WAS HOSPITALIZED FOR DIGESTIVE BLEEDING OF OBSCURE ORIGIN WHICH WAS IN THE MIDDLE PART OF THE DIGESTIVE SYSTEM, SMALL INTESTINE. THE PATIENT SWALLOWED THE CAPSULE ON (B)(6) 2021. THE PATIENT HAD NO SWALLOWING DISORDERS AND WAS ABLE TO SWALLOW THE CAPSULE WITHOUT DIFFICULTY. 5 DAYS AFTER THE STUDY WAS CARRIED OUT, THE PATIENT DIED WITH THE CAPSULE IN THE BODY. THE STUDY YIELDED NO RESULTS. THE PATIENT HAD NO DELAYED GASTRIC EMPTYING ISSUES AND NO INTERVENTION WAS DONE TO REMOVE THE CAPSULE. WHEN VIEWING THE IMAGES, THE DOCTOR WAS ABLE TO VERIFY THAT THE CAPSULE WAS MORE THAN 8 HOURS IN THE ESOPHAGUS WHEN THE NORMAL THING WAS THAT IT PASSES IN 15 SECONDS. IT STAYED 3 HOURS IN THE STOMACH WHERE THE CAPSULE WAS DEACTIVATED DUE TO HAVING EXHAUSTED THE 11 HOURS OF BATTERY. THE STUDY WAS INCOMPLETE BECAUSE THE CAPSULE DID NOT REACH THE BLIND COLON DUE TO THE SLOWING DOWN OF THE PATIENT'S TRANSIT TIMES. THE PRODUCT SPECIALIST WAS ABLE TO SEE THE VIDEO AND OBSERVED THE SAME THING THAT THE DOCTOR INDICATED R EGARDING THE TOTALLY ALTERED TRANSIT TIMES. THE CAPSULE PROGRESSED THROUGH THE MUCOSA OF THE DIGESTIVE SYSTEM, PROPELLED BY THE PERISTALTIC MOVEMEN

  Patient problems: Insufficient Information

  MAUDE report 12229112 ↗
• MalfunctionJul 31, 2020Premature Discharge of Battery

  PATIENT CAME IN FOR AN OUTPATIENT PILL CAMERA PROCEDURE ON (B)(6) 2020. THE PATIENT CALLED AROUND 11 AM AND STATED THAT HIS MACHINE TURNED OFF SHORTLY AFTER HE HAD A BOWEL MOVEMENT. MANUFACTURER WAS CALLED AND THEY STATED THAT THE PATIENT PROBABLY PASSED THE PILL IN THEIR BOWEL MOVEMENT AND THAT IT IS NORMAL FOR THE MACHINE TO SHUT OFF WHEN THE PILL GETS OUT OF RANGE (FLUSHED) AND TO HAVE THEM RETURN THE EQUIPMENT. THE INFORMATION WAS DOWNLOADED IMMEDIATELY AND GASTROENTEROLOGIST WAS NOTIFIED. THE NEXT MORNING, IT WAS NOTED THAT THE MACHINE ONLY HAD 2 BARS FOR BATTERY EVEN THOUGH IT CHARGED OVERNIGHT. WHEN GASTROENTEROLOGIST READ THE RESULTS ON (B)(6), HE SAID THAT THE PILL HAD NOT BEEN PASSED AS SUSPECTED AND THAT THE TEST STOPPED WHILE IN THE PILL WAS STILL IN THE INTESTINES AND THAT THE TEST NEEDS TO BE REPEATED. FDA SAFETY REPORT ID# (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10355717 ↗
• InjuryJan 22, 2020Insufficient Device Problem Information; Data Problem; Insufficient Device Problem Information; Data Problem

  ACCORDING TO THE REPORTER, THE RECORDER PROMPTED AN ERROR 62 MESSAGE WHICH MEANT THAT THE SD CARD CONTRIBUTED TO THE FAILURE OF THE DATA RETRIEVAL. THE PATIENT HAD TO EXTEND HOSPITALIZATION FOR ANOTHER DAY BECAUSE OF THE REPEAT PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9618617 ↗
• MalfunctionOct 8, 2019Unintended Application Program Shut Down; Unintended Application Program Shut Down

  ACCORDING TO THE REPORTER, THERE WAS A SHORT VIDEO AS ONLY THE IMAGE OF THE ESOPHAGUS WAS TAKEN. THE RECORDING ONLY LASTED FOR ABOUT 3 MINUTES, SO IT WAS NECESSARY TO PERFORM A REPEAT PROCEDURE AND ANOTHER CAPSULE WAS USED FOR THIS. THERE WAS NO USER OR PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9167876 ↗
• InjuryFeb 28, 2019Failure to Transmit Record; Unintended Application Program Shut Down; Failure to Transmit Record; Unintended Application Program Shut Down

  ACCORDING TO THE REPORTER, THE PATIENT MENTIONED THAT THE RECORDER WAS FLASHING YELLOW AFTER A BOWEL MOVEMENT. THEY REPORTED FOUR HOURS INTO THE STUDY. THE PATIENT WAS UNSURE IF THE CAPSULE WAS PASSED. A COPY OF THE STUDY WAS SENT IN FOR REVIEW AND EVALUATION AND THE STUDY DURATION WAS THREE HOURS AND 51 MINUTES. THE FULL SMALL BOWEL WAS CAPTURED AND THERE WERE NO ISSUES WITH THE STUDY. THEY ARE GOING TO ACQUIRE AN X-RAY TO CONFIRM IF THE CAPSULE HAS BEEN PASSED. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: No Information; No Known Impact Or Consequence To Patient

  MAUDE report 8377701 ↗
• InjuryJan 10, 2019Loss of Power; Unintended Application Program Shut Down; Loss of Power; Unintended Application Program Shut Down

  ACCORDING TO THE REPORTER, THEY HAD A SHORT STUDY WHICH WAS SUSPECTED TO BE DUE TO THE RECORDER TURNING OFF. THE PATIENT RETURNED THE RECORDER WITH THE STUDY DOWNLOADED WHICH WAS ONLY 4 HOURS. THEY CONFIRMED THAT THE CAPSULE DID REACH THE COLON BUT WAS CONCERNED THAT THE CAPSULE MAY HAVE "POPPED BACK OUT," SO THEY PERFORMED AN X RAY, BUT DID NOT HAVE THE RESULTS. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Radiation Exposure, Unintended

  MAUDE report 8235305 ↗
• MalfunctionJan 9, 2019Entrapment of Device; Entrapment of Device

  ACCORDING TO THE REPORTER, THE CAPSULE WAS LODGED IN THE PATIENT'S THROAT. THE PATIENT WAS ADMITTED TO THE HOSPITAL AND THE PHYSICIAN PUSHED THE CAPSULE THROUGH. THE TECHNICAL SUPPORT HAD THE CUSTOMER RECHECK-IN THE PATIENT, THEN PAIRED THE CAPSULE, AND INITIATED THE STUDY. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8232195 ↗
• InjuryNov 26, 2018Computer Software Problem; Computer Software Problem

  ACCORDING TO THE REPORTER, THE RECORDER WAS RECOGNIZED BY THE SOFTWARE AND WAS STUCK ON THE SOFTWARE VERSION SCREEN, BUT IT WORKED CORRECTLY DURING A PREVIOUS PROCEDURE. TECHNICAL SUPPORT WALKED THE CUSTOMER THROUGH RESETTING THE RECORDER, BUT IT FROZE AGAIN ON THE SOFTWARE SCREEN. THEY RESET IT AGAIN AND RE-SEATED THE SD CARD, BUT THE ISSUE PERSISTED. THE PATIENT WAS DISCHARGED HOME AFTER THE SECOND PROCEDURE. THERE WAS NO PATIENT INJURY BUT THERE WAS DELAYED CARE AND LONGER HOSPITAL STAY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8104751 ↗
• InjurySep 7, 2018Loss of Power; Defective Device; Unintended Application Program Shut Down; Loss of Power; Defective Device; Unintended Application Program Shut Down

  ACCORDING TO THE REPORTER, THEY PERFORMED AN IN PATIENT STUDY A FEW DAYS AGO, BUT THE RECORDER SHUT DOWN AFTER A VERY SHORT TIME. THE CUSTOMER NOTICED THAT THE RECORDER WAS OFF, THEY DID NOT ATTEMPT TO BEGIN THE STUDY AGAIN, NOR DID THEY CALL TECHNICAL SUPPORT AT THAT TIME, AS IT WAS OVER THE WEEKEND WHEN THIS OCCURRED. THEY DID DOWNLOAD THE STUDY AND IT WAS APPROXIMATELY 10 MINUTES LONG. THEY ALSO INQUIRED IF IT WAS "SAFE" TO PERFORM A STUDY ON THIS SAME PATIENT TODAY, EVEN THOUGH THEY WERE NOT ABLE TO CONFIRM EXCRETION OF THE CAPSULE. TECHNICAL SUPPORT INFORMED THEM THAT IT WAS MORE THAN LIKELY THAT THE CAPSULE BATTERY HAD DIED, BUT IS STILL BETTER TO CONFIRM THE CAPSULE HAS PASSED BY X-RAY IF NECESSARY. THE CUSTOMER UPDATED THAT AN X-RAY HAS BEEN PERFORMED IN TWO DIFFERENT DAYS, AND IT BOTH SHOWED THE CAPSULE WAS STILL INTACT IN THE PATIENT'S GASTROINTESTINAL TRACT. A COPY OF THE STUDY WILL BE SENT IN FOR REVIEW. THE RECORDER AND SENSOR BELT WORKED CORRECTLY DURING THE PREVIOUS PROCEDURE. TECHNICAL SUPPORT REVIEWED THE STUDY AND THE SENSOR BELT BECAUSE THE GAPS AD THE STUDY ENDED PREMATURELY. THERE WERE SEVERAL INSTANCES OF "ENERGY TOO LOW/HIGH.". THERE WAS NO REPORTED PATIENT O

  Patient problems: Radiation Exposure, Unintended

  MAUDE report 7855871 ↗