Pillcam FGS-0497Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 07290101364351), received between Jul 18, 2018 and Apr 8, 2022 — classified as 7 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Entrapment of Device” (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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryApr 8, 2022Entrapment of Device; Entrapment of Device

  ACCORDING TO THE REPORTER, THE CAPSULE WAS RETAINED INSIDE THE PATIENT'S BODY. THE CUSTOMER HAD NO SYMPTOMS OR SIDE EFFECTS. X-RAY WAS DONE AND CAPSULE WAS ON THE LEFT SIDE OF THE QUADRANT AND HAD NOT CHANGE POSITION SINCE THE PREVIOUS EXAM. THE PATIENT HAD REGULAR BOWEL MOVEMENT AND THE CAPSULE WAS STILL THERE. THE PATIENT HAD COLON SURGERY IN THE PAST.

  Patient problems: Foreign Body In Patient; Unintended Radiation Exposure

  MAUDE report 14058334 ↗
• MalfunctionNov 26, 2019Human-Device Interface Problem; Human-Device Interface Problem

  ACCORDING TO THE REPORTER, THE PATIENT HAD A HARD TIME INGESTING THE CAPSULE AND IT WAS STUCK ON THE PATIENT'S THROAT. THE PATIENT CONDITIONAL CAPSULE PASSED NORMALLY. FILES WAS TRANSFERRED THE OVER FOR REVIEW, THE LOG FILES SHOWED THAT THE SENSOR WAS DISCONNECTED AND THE NAVIGATION WAS PRESSED DURING THE DURATION OF THE PROCEDURE. THE BATTERY OF THE RECORDER WAS AT 96%, AND THERE WAS NO EQUIPMENT FAILURE. THERE WAS NO IMPLANTED DEVICES OR TELEMETRY PRESENT. THERE WAS NO PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9375397 ↗
• InjuryMar 19, 2019Entrapment of Device; Entrapment of Device

  ACCORDING TO THE REPORTER, THE CUSTOMER CALLED TO INQUIRE ABOUT THE DIMENSIONS OF THE CAPSULE, BECAUSE THE CUSTOMER BELIEVED THAT THE CAPSULE WAS RETAINED BY PATIENT. THE PATIENT HAD AN X-RAY AND THEY OBSERVED METAL OBJECT ON THE X-RAY IMAGE. THE PATIENT HAD BEEN ASYMPTOMATIC AND CAME IN FOR A ROUTINE FOLLOW-UP. THE CAPSULE HAD REACHED THE COLON AS WHAT SEEN ON THE VIDEO. IT WAS EXPLAINED TO THE CUSTOMER THAT IT WOULD BE EXTREMELY RARE FOR CAPSULE RETENTION IN THE COLON AND AGREED TO SHARE A RADIOGRAPH DEMONSTRATED THE CAPSULE ON THE X-RAY FOR FURTHER REVIEW.

  Patient problems: Radiation Exposure, Unintended

  MAUDE report 8432074 ↗
• InjuryMar 6, 2019Entrapment of Device; Entrapment of Device

  ACCORDING TO THE REPORTER, THE CAPSULE WAS STUCK IN THE PATIENT¿S STOMACH AND HAD AN OCCULT BLOOD IN STOOL, BUT THERE WERE NO PICTURES WERE CAPTURED. A WEEK LATER, THE PATIENT WANTED TO KNOW IF THE CAPSULE HAS BEEN EXCRETED. THE PHYSICIAN ORDERED AN X-RAY, WHICH WAS READ BY THE RADIOLOGIST AS THE CAPSULE BROKEN APART IN 2 PIECES, BOTH APPEARING IN THE COLON. THE PATIENT HAS NEVER HAD ANY OTHER CAPSULE OR PATENCY CAPSULE PROCEDURE. THE PATIENT WAS COMPLETELY ASYMPTOMATIC.

  Patient problems: No Code Available; Radiation Exposure, Unintended

  MAUDE report 8394072 ↗
• 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 8377702 ↗
• 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 8235353 ↗
• MalfunctionJan 3, 2019Human-Device Interface Problem; Data Problem; Unintended Application Program Shut Down; Human-Device Interface Problem; Data Problem; Unintended Application Program Shut Down

  ACCORDING TO THE REPORTER, THEY HAD AN ERROR OF "STUDY DOES NOT CONTAIN VIDEO." THE CUSTOMER PERFORMED A PROCEDURE TO WHEREAS THE PATIENT HAD AN ISSUE SWALLOWING THE CAPSULE. THE PATIENT ATTEMPTED APPROXIMATELY 45 MINUTES, THEN THE CAPSULE WAS PLACED BY ESOPHAGOGASTRODUODENOSCOPY. THE RECORDER LOST THE CAPSULE SIGNAL AND THEY WERE PRESENTED WITH AN END OF PROCEDURE MESSAGE. THE CUSTOMER CHECKED IN THE PATIENT WITH ANOTHER RECORDER AND CONNECTED THE SAME SENSOR BELT, THEY HAD ISSUES PAIRING THE CAPSULE, BUT LATER ON IT WAS PAIRED. THEY STARTED THE VIDEO CREATION IN THE FIRST RECORDER, THEN TECH SUPPORT INSTRUCTED THE CUSTOMER TO ALLOW PROCESS TO COMPLETE, AND THEN CHECK TO SEE IF THE OTHER VIDEO WAS CREATED IN THE OTHER RECORDER. THERE WAS NO REPORTED PATIENT INVOLVEMENT OR OUTCOME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8212478 ↗
• InjuryOct 22, 2018Failure to Transmit Record; Failure to Transmit Record

  ACCORDING TO THE REPORTER, THE DEVICE FAILED TO TRANSMIT. THEY WERE ABLE TO PAIR THE CAPSULE AND SEE AN IMAGE. THE PATIENT TOOK THE CAPSULE AND IT STOPPED RECORDING. THE CUSTOMER GOT A NEW RECORDER AND BELT, TRIED TO CHECK IN THE PATIENT AGAIN TO SEE IF IT WOULD CONNECT BUT THE CAPSULE WAS NOT CONNECTED. NO HARM HAS BEEN NOTED AND PATIENT RECEIVED FOLLOW UP X RAY TO VERIFY THAT THE CAPSULE HAS LEFT THE BODY AND WENT ON TO HAD A SUCCESSFUL CAPSULE ENDOSCOPY.

  Patient problems: Radiation Exposure, Unintended

  MAUDE report 7990268 ↗
• InjuryJul 18, 2018Entrapment of Device; Device Dislodged or Dislocated; Physical Resistance/Sticking; Entrapment of Device

  ACCORDING TO THE REPORTER, THE CAPSULE WAS STUCK IN THE CECUM FOR ALMOST SIX DAYS. AN X-RAY WAS PERFORMED TO CONFIRM IF THE CAPSULE WAS STILL PRESENT. THE CUSTOMER HAS REQUESTED FOR RECOMMENDATIONS ON THE NEXT STEPS. TECHNICAL SUPPORT INFORMED THE MEDICAL ADVISORS. THE PATIENT IS STABLE WITH NO HARM AND WAS IN THE HOSPITAL AS AN INPATIENT.

  Patient problems: Foreign Body In Patient; Radiation Exposure, Unintended

  MAUDE report 7700553 ↗