PillCam FGS-0501Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 07290101364399), received between Apr 11, 2018 and Mar 22, 2024 — classified as 19 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Entrapment of Device” (21 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 25 most recent of 27 reports, in the reporter's own words as published by the FDA.

• InjuryMar 22, 2024Entrapment of Device; Entrapment of Device

  ACCORDING TO THE REPORTER, THE CAPSULE WAS STUCK IN PATIENT'S THROAT. PATIENT HAD TO GO TO EMERGENCY ROOM TO HAVE IT REMOVED BY LARYNGOSCOPY AND WAS SYMPTOMATIC.

  Patient problems: Obstruction/Occlusion

  MAUDE report 18964917 ↗
• InjuryJan 17, 2023Entrapment of Device; Entrapment of Device

  ACCORDING TO THE REPORTER, THE CAPSULE WAS IN THE SMALL BOWEL. THE PATIENT STILL HAS NOT PASSED THE CAPSULE AFTER 3 MONTHS FROM PROCEDURE DATE. NO PATENCY WAS DONE PRIOR TO CAPSULE INGESTION. THE LAST CAPSULE IMAGE OF SMALL BOWEL WAS AT 14 HOURS, AND IT WAS AN INCOMPLETE EVALUATION OF THE SMALL BOWEL. 9 DAYS AFTER THE PROCEDURE AN ULTRASOUND OF KUB (KIDNEYS, URETERS AND BLADDER) WAS DONE, AND ON THE LEFT LOWER QUADRANT THE CAPSULE WAS NOTED. TWO REPEAT KUB ULTRASOUND WAS DONE ON DIFFERENT DATES WITH THE SAME RESULTS. THE PATIENT WAS ADMITTED WITH COMPLAINTS OF PANCREATITIS SYMPTOMS AND WAS DIAGNOSED WITH SBO (SMALL BOWEL OBSTRUCTION). KUB ULTRASOUND WAS DONE ON THE SAME DAY OF ADMISSION, WITH NO CHANGES ON THE CAPSULE PLACEMENT. CT SCAN WAS ALSO DONE WITH THE RESULTS OF COLONIC DIVERTICULA, DISTENDED STOMACH, MULTIPLE SMALL BOWEL LOOP DISTENDED, AND METAL OBJECT IN SMALL BOWEL LOOP. THE PATIENT WAS DISCHARGED THREE DAYS AFTER ADMISSION. A FOLLOW-UP CT SCAN WAS DONE WITH METAL ARTIFACT IN THE RIGHT LOWER QUADRANT. THE PATIENT WAS RECOMMENDED FOR DOUBLE BALLOON OR SURGERY TO REMOVE DEVICE.

  Patient problems: Foreign Body In Patient; Obstruction/Occlusion; Unintended Radiation Exposure

  MAUDE report 16183988 ↗
• MalfunctionMay 6, 2022Human-Device Interface Problem; Human-Device Interface Problem

  ACCORDING TO THE REPORTER, A CAPSULE WAS STUCK IN THE PATIENT'S THROAT AND WAS ABLE TO COUGH OUT THE CAPSULE. THE CUSTOMER WAS LOOKING TO PLACE THE CAPSULE. THE PATIENT COULD NOT INGEST THE CAPSULE. THE PATIENT WAS DOING WELL WITH NO HARM.

  Patient problems: Airway Obstruction; Cough

  MAUDE report 14306637 ↗
• InjuryApr 15, 2022Entrapment of Device; Entrapment of Device

  ACCORDING TO THE REPORTER, AN MRI SCAN WAS DONE ON (B)(6) 2021. ALSO, A CT ON PELVIS AND ABDOMEN WAS DONE AND SHOWN THAT THERE WAS A METALLIC FOREIGN OBJECT IN THE PATIENT SMALL BOWEL ON (B)(6) 2022. IT WAS SEEN IN THE RIGHT SIDE OF THE SMALL BOWEL LOOP. THE PATIENT HAS RETAINED THE CAPSULE SINCE (B)(6) 2020. THE PATIENT HAD NO SYMPTOMS. THE PATIENT HAD A COLONOSCOPY, AND HAS HAD A CAT SCAN AND X-RAY AND THE CAPSULE HAD NOT MOVED.

  Patient problems: Discomfort; Foreign Body In Patient

  MAUDE report 14120968 ↗
• MalfunctionSep 13, 2021Human-Device Interface Problem; Unintended Application Program Shut Down; Human-Device Interface Problem; Unintended Application Program Shut Down

  ACCORDING TO THE REPORTER, THEY HAD A SHORT STUDY OF ONLY 17 MINUTES. TECHNICAL SUPPORT REVIEWED THE LOG FILES AND IT SHOWS THAT THE CUSTOMER WAS NOT ABLE TO INGEST THE CAPSULE. THERE WAS NO PATIENT OR USER HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12465632 ↗
• InjuryJun 3, 2021Entrapment of Device; Entrapment of Device

  ACCORDING TO THE REPORTER, THE CAPSULE HAD BEEN STUCK IN THE PATIENT FOR A YEAR. AN X-RAY WAS DONE TO CONFIRM THAT THE CAPSULE WAS RETAINED. THE PATIENT HAD A STROKE AND THEY WANTED TO KNOW IF MRI CAN BE PERFORMED.

  Patient problems: Foreign Body In Patient; Unintended Radiation Exposure

  MAUDE report 11929604 ↗
• InjuryJan 15, 2021Entrapment of Device

  ACCORDING TO THE REPORTER, THE CAPSULE WAS RETAINED IN THE PATIENT'S BODY. THREE X-RAYS WERE TAKEN. PATIENT WAS DOING FINE. THERE WAS NO SYMPTOMS RELATED TO THE RETAINED CAPSULE. THERE WAS NO STRICTURES NOTED. PATIENT HAD NOT YET SEEN FOR SURGERY CONSULT AND ORDERED MRI IN WHICH BOTH NEVER COMPLETED. THEY REFERRED THE PATIENT BACK FOR SURGERY ADVISE.

  Patient problems: Foreign Body In Patient; Unintended Radiation Exposure

  MAUDE report 11175980 ↗
• MalfunctionSep 28, 2020Entrapment of Device; Entrapment of Device

  ACCORDING TO THE REPORTER, THEY HAVE A RETAINED CAPSULE. THERE WAS NO PATIENT AND USER HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10592080 ↗
• InjuryMar 25, 2020Entrapment of Device; Entrapment of Device

  ACCORDING TO THE REPORTER, THEY HAD A PATIENT IN WHICH THE CAPSULE WAS RETAINED FOR OVER 7 MONTHS. PATENCY CAPSULE WAS PERFORMED PRIOR TO THE PROCEDURE. THE PATIENT REPORTED VOMITING, DISCOMFORT, AND LOSING WEIGHT BUT IT WAS UNCLEAR WHETHER OR NOT THIS HAS BEEN CONTINUOUS AND FOR HOW LONG THIS HAS BEEN GOING ON. THE CAPSULE RETENTION WAS VERIFIED INITIALLY THROUGH ABDOMINAL X-RAY AND IT SHOWED THAT IT HAD NOT REACHED THE CECUM. THIS WAS ALSO CONFIRMED WITH A SUBSEQUENT CT SCAN. THE PATIENT WENT THROUGH SEVERAL SERIAL ABDOMINAL X-RAYS TO ASSESS PASSAGE. ONCE IT WAS APPARENT THAT THE CAPSULE HAD NOT PASSED AFTER SEVERAL WEEKS, IT WAS RECOMMENDED TO HAVE THE PATIENT START CORTICOSTEROIDS FOR ACTIVE INFLAMMATION SECONDARY TO CROHN'S DISEASE IN WHICH THE PATIENT REFUSED. THEY SUSPECTED THAT THE CAPSULE WAS STUCK PROXIMAL TO AN INFLAMMATORY STRICTURE AND TREATMENT OF THIS MAY AID IN CAPSULE PASSAGE. IT WAS ALSO RECOMMENDED THAT THE PATIENT START BIOLOGIC THERAPY WHICH THE PATIENT ALSO REFUSED. THE PATIENT WAS REFERRED TO AN INSTITUTION THAT COULD PERFORM DOUBLE BALLOON ENTEROSCOPY BUT WAS NOT ABLE TO BE SEEN THERE. THE PATIENT UNDERWENT RETROGRADE SINGLE BALLOON ENTEROSCOPY WHICH FAILED

  Patient problems: Discomfort; Inflammation; Injury; No Information; Radiation Exposure, Unintended; Vomiting; Weight Changes

  MAUDE report 9881010 ↗
• MalfunctionMar 18, 2020Entrapment of Device; Entrapment of Device

  ACCORDING TO THE REPORTER, WHEN THE PHYSICIAN REVIEWED THE STUDY AND FOUND THAT PATIENT HAD STRICTURES AND CAPSULE WAS STUCK IN SMALL BOWEL. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: No Information

  MAUDE report 9847260 ↗
• MalfunctionMar 16, 2020Entrapment of Device; Entrapment of Device

  ACCORDING TO THE REPORTER, THEY HAD A PATIENT THAT HAD A RETAINED CAPSULE SINCE (B)(6) 2019. THE CUSTOMER WANTED TO KNOW HOW LONG BEFORE THE CAPSULE STARTED TO CORRODE. THERE WAS NO PATIENT AND USER HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9835489 ↗
• InjuryDec 23, 2019Entrapment of Device; Entrapment of Device

  ACCORDING TO THE REPORTER, THE CAPSULE WAS RETAINED ON (B)(6). THE PHYSICIAN ORDERED A CT SCAN ON (B)(6) AND IT SHOWED THAT THE CAPSULE WAS STILL IN THE PATIENT. THEY HAD ANOTHER CT SCAN ON (B)(6) AND IT WAS STILL SHOWING ON THE SAME SPOT. THE PATIENT HAD NOT PASSED THE CAPSULE YET. THE PATIENT WAS SENT TO SURGEON TO DISCUSS POSSIBLE SURGICAL REMOVAL. THE PATIENT'S PRE-PROCEDURE DIAGNOSIS WAS ANEMIA. THE PATIENT CURRENTLY HAD NO COMPLAINTS OF ABDOMINAL PAIN. THE PATIENT HAD MOVING BOWELS WITH NO PROBLEM.

  Patient problems: Radiation Exposure, Unintended

  MAUDE report 9513645 ↗
• InjuryJul 9, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, THE PATIENT SUFFERED A STROKE AFTER A CAPSULE PROCEDURE. THE PATIENT WAS IN STABLE CONDITION AND CURRENTLY BEING TREATED FOR STROKE SYMPTOMS. THEY BELIEVED THAT THE CAPSULE WAS NOT INVOLVED IN STROKE.

  Patient problems: Infarction, Cerebral

  MAUDE report 8771999 ↗
• InjuryJun 13, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, THE PATIENT FELL ILL ALMOST IMMEDIATELY AFTER INGESTION OF THE CAPSULE. THE PATIENT COMPLAINED OF SUDDENLY BEING VERY WEAK SO THEY TOOK THE PATIENT'S BLOOD PRESSURE AND IT WAS VERY LOW, SO THE PHYSICIAN ADVISED THEM TO TAKE THE PATIENT TO THE ER RIGHT AWAY TO DETERMINE WHAT WAS GOING ON. THE SITUATION EVENTUALLY RESOLVED WITHOUT SEQUELAE. THE PATIENT WAS AN ELDERLY WHO UNDERWENT CAPSULE ENDOSCOPY DUE TO ANEMIA. THEY ASSUMED THAT THE PATIENT MAY HAVE HAD VASOVAGAL REACTION AFTER INGESTING THE CAPSULE AND THOUGHT THAT THE ANEMIA MAY HAVE PLAYED A ROLE IN IT AS WELL. THE PATIENT EVENTUALLY FELT FINE.

  Patient problems: Low Blood Pressure/ Hypotension

  MAUDE report 8696691 ↗
• MalfunctionApr 30, 2019Entrapment of Device; Entrapment of Device

  ACCORDING TO THE REPORTER, THE PATIENT INGESTED THE CAPSULE FOR SEVERAL DAYS AND IT WAS STILL PRESENT IN THE RECTUM. THE PHYSICIAN PERFORMED AN MRI WITHOUT KNOWLEDGE THAT THE PATIENT HAD A PROCEDURE. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: No Information

  MAUDE report 8566786 ↗
• MalfunctionApr 26, 2019Entrapment of Device; Entrapment of Device

  ACCORDING TO THE REPORTER, THE CAPSULE WAS RETAINED FOR OVER 6 WEEKS. THE PATIENT WAS IN GOOD CONDITION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8555904 ↗
• InjuryApr 24, 2019Entrapment of Device; Entrapment of Device

  ACCORDING TO THE REPORTER, THEY HAD A RETAINED CAPSULE FOR TWO WEEKS. AN X-RAY WAS PERFORMED AND VERIFIED THAT THE CAPSULE WAS IN THE RECTUM. THE PATIENT EXPERIENCED NO PAIN AND IN GOOD CONDITION.

  Patient problems: Radiation Exposure, Unintended

  MAUDE report 8547600 ↗
• InjuryApr 4, 2019Entrapment of Device; Entrapment of Device

  ACCORDING TO THE REPORTER, THE PATIENT HAD A RETAINED CAPSULE AS THE CAPSULE WAS INGESTED ABOUT 10 DAYS AGO. THE PATIENT UNDERWENT A HYPERBARIC CHAMBER THERAPY FOR A LOWER EXTREMITY WOUND WHICH WAS IMPROVING WITH TREATMENT. IT APPEARED THAT THE WOUND MAY HAVE WORSENED SOMEWHAT WITH THE THERAPY BEING ON HOLD. THE PHYSICIAN WAS NOT COMFORTABLE CLEARING THE PATIENT WITH THE CAPSULE STILL INSIDE, TO THE POINT THAT 3 KIDNEY, URETER, BLADDER STUDIES WERE PERFORMED POST CAPSULE INGESTION, LAXATIVE TREATMENT WAS ATTEMPTED, AND THAT ENEMAS WERE SCHEDULED TO ENCOURAGE PASSAGE.

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

  MAUDE report 8485131 ↗
• InjuryMar 29, 2019Entrapment of Device; Entrapment of Device

  ACCORDING TO THE REPORTER, THE CAPSULE SHOWED UP IN AN X-RAY TWO DAYS AFTER INGESTION. THEY WERE ADVISED TO TAKE AN X-RAY ON DAY 15TH OF THE PROCEDURE. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Injury; Radiation Exposure, Unintended

  MAUDE report 8465725 ↗
• MalfunctionFeb 26, 2019Entrapment of Device; Entrapment of Device

  ACCORDING TO THE REPORTER, THE CAPSULE BECAME LODGED IN THE PATIENT'S HERNIA. THE PATIENT WAS INQUIRED IF HE CAN INGEST ANOTHER CAPSULE AND WAS INFORMED THAT THE PATIENT SHOULD INGEST ANOTHER CAPSULE IF IT HAS BEEN VERIFIED THAT THE CAPSULE HAS BEEN PASSED OR REMOVED. IT WAS STATED THAT THE PHYSICIANS WILL REMOVE THE CAPSULE AND PERFORM THE STUDY AGAIN ONCE THE CAPSULE HAS BEEN PASSED OR REMOVED FROM THE PATIENT.

  Patient problems: Hernia; No Code Available

  MAUDE report 8370837 ↗
• InjuryJan 2, 2019Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, THE CAPSULE WAS ASPIRATED INTO THE PATIENT'S LUNGS. THE PATIENT UNDERWENT AN X-RAY TO VERIFY THE CAPSULE LOCATION AND UNDERWENT A SURGERY TO REMOVE IT. THE CAPSULE WAS PLACED IN THE DUODENUM TO COMPLETE THE STUDY. THE RECORDER WAS REMOVED FROM THE PATIENT AND THE VIDEO WAS DOWNLOADED AND THEN IT WAS PLACED BACK TO THE PATIENT WITHOUT RECHECKING-IN. TECHNICAL SUPPORT INFORMED THE CUSTOMER THAT THE DATA COULD NOT BE POSSIBLY OBTAINED SINCE THE PATIENT WAS NOT CHECKED-IN POST-SURGERY. TECHNICAL SUPPORT CONFIRMED WITH THE CUSTOMER THAT THE PATIENT UNDERWENT THE ADDITIONAL SURGERY, BUT WAS CLINICALLY DOING WELL.

  Patient problems: Aspiration/Inhalation; Radiation Exposure, Unintended

  MAUDE report 8208505 ↗
• InjuryNov 27, 2018Entrapment of Device; Entrapment of Device

  ACCORDING TO THE REPORTER, THE CAPSULE WAS RETAINED IN THE PATIENT AND THEY HAD BEEN IN TOUCH WITH THE PHYSICIAN. THE PATIENT WAS CURRENTLY STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8107964 ↗
• InjuryNov 16, 2018Entrapment of Device; Entrapment of Device

  ACCORDING TO THE REPORTER, THEY HAD A PATIENT WHO HAD A RETAINED CAPSULE. THE PHYSICIAN MADE AN INQUIRY REGARDING OTHER DOCTORS WHO COULD PERFORM THE REMOVAL OF THE CAPSULE, BECAUSE OF THE INABILITY TO PERFORM A DOUBLE-BALLOON ENTEROSCOPY. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8077950 ↗
• InjuryNov 12, 2018Entrapment of Device; Entrapment of Device

  ACCORDING TO THE REPORTER, THE PATIENT WAS TRANSFERRED FOR REMOVAL OF THE CAPSULE FROM THE PATIENT'S LUNG. THE CAPSULE WAS SUCCESSFULLY REMOVED VIA BRONCHOSCOPY AND THE PATIENT RECOVERED WITHOUT FURTHER DIFFICULTY, AND WAS DISCHARGED. THERE WAS NO FURTHER PATIENT INJURY REPORTED.

  Patient problems: Aspiration/Inhalation

  MAUDE report 8061065 ↗
• InjuryOct 3, 2018Entrapment of Device; Entrapment of Device

  ACCORDING TO THE REPORTER, THE PATIENT COMPLAINED OF COUGHING A LOT AND THAT THE CAPSULE FELT STUCK AFTER INGESTING IT. THE CUSTOMER INFORMED THAT THE RECORDER WAS FLASHING YELLOW AND WENT TO ADAPTIVE FREQUENCY RESPONSE TO AN EXCLAMATION MARK. TECHNICAL SUPPORT INFORMED THE CUSTOMER THAT SINCE THE RECORDER WAS FLASHING YELLOW FOR 20-30 MINUTES, THE UNIT WENT INTO END OF PROCEDURE MODE AND HAD STOPPED RECORDING. AS PER THE CUSTOMER, THEY PERFORMED AN ESOPHAGEAL GASTRODUODENOSCOPY AND DID NOT SEE THE CAPSULE, SO THEY WILL HAVE THE PATIENT TAKE X-RAYS TO CONFIRM IF THE CAPSULE WAS PASSED BEFORE HAVING THE PATIENT INGEST A SECOND CAPSULE. TECH SUPPORT INFORMED THE CUSTOMER TO CREATE THE VIDEO AND RECHECK IN THE PATIENT TO SEE IF THEY CAN RESUME RECORDING. THE X-RAY FINDINGS SHOWED THAT THE CAPSULE WAS IN THE RIGHT BRONCHUS. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Radiation Exposure, Unintended

  MAUDE report 7929717 ↗