Pillcam FGS-0109Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 07290101360629), received between Apr 17, 2018 and Nov 11, 2022 — classified as 12 injuries, 1 malfunction.

The most frequently reported specific device problem is “Entrapment of Device” (9 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 11, 2022Entrapment of Device; Entrapment of Device

  ACCORDING TO THE REPORTER, A CAPSULE WAS RETAINED IN THE ASCENDING COLON. THE PATIENT WAS STABLE.

  Patient problems: Insufficient Information

  MAUDE report 15782473 ↗
• InjuryMar 29, 2021Entrapment of Device; Entrapment of Device

  ACCORDING TO THE REPORTER, THE PATIENT WHO HAD THE PATENCY CAPSULE 2 WEEKS AGO HAS STILL GOT THE PATENCY IN THE SMALL BOWEL. IT WAS THOUGHT ON X-RAY THAT THE PATENCY WAS IN THE RECTUM, SO THEY WENT AHEAD AND HAD THE CAPSULE ENDOSCOPY BUT GOT HELD UP BEHIND A STRICTURE PROBABLY IN A LOOP OF SMALL BOWEL SITTING OVER THE RECTUM. THE PATENCY WAS SEEN THRU THE CAPSULE ENDOSCOPY, SQUASHED DOWN BUT STILL THERE. IT WAS ALSO REPORTED THAT THE PILLCAM CAPSULE WAS ALSO RETAINED. THE PATIENT IS DUE FOR SURGERY TO REMOVE THE STRICTURE, PATENCY CAPSULE AND PILLCAM.

  Patient problems: Foreign Body In Patient; Unintended Radiation Exposure

  MAUDE report 11581632 ↗
• InjuryJul 23, 2020Entrapment of Device; Entrapment of Device

  ACCORDING TO THE REPORTER, A PATIENT WITH CROHN'S DISEASE, HAD AN INTACT AND STUCK PATENCY CAPSULE 48 HOURS AFTER INGESTION. AN X-RAY SHOWED AN INTACT PATENCY CAPSULE AND THE PATENCY CAPSULE SHOWED NO SIGNS OF DECAY AT THE 30 HOUR MARK AND HAD CREATED AN OBSTRUCTION OF THE STOMA. THE PATIENT WAS ADMITTED TO THE HOSPITAL, AND THE CAPSULE WAS LOCATED AND REMOVED BY SCOPE. THE CAPSULE WAS PREDOMINANTLY INTACT, BUT THE ENDS OF IT WAS BLACK. THE CAPSULE WAS CAUGHT ON A STRICTURE CLOSE TO THE STOMA. THE COMPUTERIZED TOMOGRAPHY (CT) SCAN HIGHLIGHTED MORE INFLAMMATION THAN WHAT WAS EXPECTED, RESULTING IN CHANGE TO TREATMENT OF THE PATIENT'S CONDITION AND DILATION OF THE STRICTURE WAS PERFORMED WHEN THE CAPSULE WAS REMOVED. THE PATIENT WAS NOT OBESE AND HAS BEEN DISCHARGED OF THE HOSPITAL.

  Patient problems: Abdominal Pain; Obstruction/Occlusion; Radiation Exposure, Unintended; Unintended Radiation Exposure; Vomiting

  MAUDE report 10316967 ↗
• InjuryJan 28, 2020Entrapment of Device; Entrapment of Device

  ACCORDING TO THE REPORTER, THE PATENCY CAPSULE WAS RETAINED FOR OVER 72 HOURS. THERE WAS NO PATIENT AND USER HARM.

  Patient problems: No Consequences Or Impact To Patient; Radiation Exposure, Unintended

  MAUDE report 9640140 ↗
• InjurySep 24, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, THE PATENCY CAPSULE DID NOT DISSOLVE. IT WAS STATED THAT THE PATIENT WAS SYMPTOMATIC AND THE CAPSULE ITSELF WAS VISIBLE ON CT SCAN. AN X-RAY WAS PERFORMED TO VERIFY STATUS OF THE CAPSULE.

  Patient problems: Radiation Exposure, Unintended

  MAUDE report 9112517 ↗
• InjuryJun 28, 2019Entrapment of Device; Entrapment of Device

  ACCORDING TO THE REPORTER, THE CAPSULED FAILED TO DISSOLVE AND THE PATIENT EXPERIENCED GASTROINTESTINAL PROBLEMS DUE TO THIS FAILURE, SO AN OPERATION WAS REQUIRED TO REMOVE THE CAPSULE WHICH ALSO REQUIRED AN EXTENDED HOSPITALIZATION OF OVER ONE WEEK. THE CAPSULE WAS INGESTED AND REMOVED. A REPEAT PROCEDURE WAS NOT NECESSARY.

  Patient problems: Foreign Body In Patient

  MAUDE report 8746659 ↗
• InjuryNov 8, 2018Entrapment of Device; Entrapment of Device

  ACCORDING TO THE REPORTER, THE PATENCY CAPSULE WAS RETAINED. WHEN THE CAPSULE WAS GIVEN THE CUSTOMER RETURNED A MONTH AFTER AND COMPLAINED OF ABDOMINAL PAIN. THEY CARRIED OUT AN X-RAY AND COMPUTED TOMOGRAPHY SCAN (CT-SCAN) WHICH SHOWED CAPSULE WAS STILL IN SITE, THEY CARRIED OUT ANOTHER X-RAY AND IT SHOWED THE SAME THING THAT THE CAPSULE WAS INTACT IN THE SITE.

  Patient problems: Abdominal Pain; Radiation Exposure, Unintended

  MAUDE report 8051272 ↗
• InjuryNov 2, 2018Entrapment of Device; Entrapment of Device

  ACCORDING TO LITERATURE SOURCE OF STUDY PERFORMED, ONE PATIENT HAD A SYMPTOMATIC PATENCY CAPSULE RETENTION MANIFESTING WITH ABDOMINAL PAIN AND VOMITING. THE PATIENT WAS TREATED WITH CORTICOSTEROIDS WITH SUBSEQUENT RESOLUTION OF THE SYMPTOMS WITHIN 2 DAYS. ARTICLE: DETECTION OF SMALL BOWEL MUCOSAL HEALING AND DEEP REMISSION IN PATIENTS WITH KNOWN SMALL BOWEL CROHN¿S DISEASE USING BIOMARKERS, CAPSULE ENDOSCOPY, AND IMAGING AUTHOR: URI KOPYLOV , MD, YEAR: 2015 SEPTEMBER VOLUME110.

  Patient problems: Abdominal Pain; Vomiting

  MAUDE report 8035216 ↗
• InjuryOct 1, 2018Human-Device Interface Problem; Human-Device Interface Problem

  ACCORDING TO THE REPORTER, THE RECORDER STOPPED WORKING AN HOUR AFTER THE START OF THE PROCEDURE. TECHNICAL SUPPORT HAD THE CUSTOMER CHECK IN PATIENT ON THE SECOND RECORDER AND TO PLACE THE FIRST RECORDER IN FRONT OF THE PATIENT NAME AT CHECK IN SO IT DOES NOT DELETE THE FIRST VIDEO. THE CUSTOMER INFORMED THAT THE RECORD DID NOT FLASHED YELLOW LED. TECHNICAL SUPPORT PROVIDED THE STEPS ON HOW TO COPY THE RAW DATA AND ONCE DONE, TO CHECK ON A PATIENT ON THE SAME RECORDER. THE CUSTOMER SUCCESSFULLY COPIED THE RAW DATA AND CHECKED IN PATIENTS. THEY INFORMED THAT THE PATIENT SPIT OUT THE CAPSULE CASE AND JUST THE OUTER LAYER OF THE CAPSULE AND ALSO CONFIRMED PATIENT REPORTING OF SORE THROAT OR PAIN, AND THEN THE PATIENT FELT COMFORT WHEN THEY SPIT OUT THE CAPSULE, BUT THE SAME THING HAPPENED APPROXIMATELY AN HOUR AND A HALF AFTER WHEN THE PATIENT INGESTED THE PATENCY CAPSULE THE DAY BEFORE THE PROCEDURE. THE CUSTOMER REACHED OUT AND STATED THAT A PHYSICIAN ADVISED THEM TO HAVE THE PATIENT SWALLOW THE SAME PATENCY CAPSULE AND AT MIDNIGHT AN X-RAY WAS DONE TO CHECK THE PATENCY CAPSULE, BUT THERE WAS NO TRACE. THE PATIENT THEN SWALLOWED THE CAPSULE THE DAY AFTER, THEN INITIALLY, THE BLUE L

  Patient problems: Radiation Exposure, Unintended

  MAUDE report 7923288 ↗
• InjurySep 27, 2018Material Fragmentation; Material Fragmentation

  ACCORDING TO THE REPORTER, THERE WAS AN UNDISSOLVED PATENCY CAPSULE FOUND IN THE PATIENT¿S FECES WITH BLOOD FROM A RELATIVELY SMALL BOWEL STENOSIS. THE CAPSULE ONLY DISSOLVED A LITTLE AT BOTH ENDS, WHICH SHOULD HAVE BEEN DISSOLVED AFTER 36 HOURS. THE PATIENT HAD ILEUS SYMPTOMS, WHICH LED TO HOSPITALIZATION AND THEN THE PATIENT DID NOT HAVE LATER COMPLICATIONS AFTER THE HOSPITALIZATION. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7916680 ↗
• InjurySep 18, 2018Entrapment of Device; Entrapment of Device

  ACCORDING TO THE REPORTER, THE PATENCY CAPSULE WAS STILL IN THE ASCENDING COLON OF THE PATIENT AS CONFIRMED BY THE COMPUTED TOMOGRAPHY AND THREE X-RAY'S. THE PATIENT WAS THEN ADMITTED FOR GASTROINTESTINAL BLEEDING AND HAS A HISTORY OF COLON CANCER. THE MEDICAL ADVISOR EXPLAINED TO THE CUSTOMER THAT THE PATENCY CAPSULE WILL DISSOLVE AND WILL BE EXPULSED NATURALLY, AND THAT IT WILL BE DEFINED AS A RETAINED CAPSULE AFTER FIFTEEN DAYS. THE PATIENT HAD A HISTORY OF PRIOR GASTROINTESTINAL BLEEDING, MELENA, AND COLON CANCER. THE PATIENT IS STILL HOSPITALIZED, ADDITIONAL DIAGNOSIS PNEUMONITIS AND WILL CONTINUE TO BE MONITORED AND THE PHYSICIAN WILL DECIDE THE BEST ACTION. THE X-RAY SHOWED SOME COLONIC DIVERTICULAR PRESENT AND THE CAPSULE WAS SEEN.

  Patient problems: Cancer; Radiation Exposure, Unintended

  MAUDE report 7887381 ↗
• InjuryJun 20, 2018Material Fragmentation; Material Fragmentation

  ACCORDING TO THE REPORTER, THE PATIENT EXPERIENCED PROJECTILE VOMITING OF SLIMY MATERIAL AND EPIGASTRIUM PAIN. TECHNICAL SUPPORT FORWARDED THE COMPLAINT TO THE MEDICAL STAFF. THE CUSTOMER HAD A CONVERSATION WITH THE MEDICAL STAFF THROUGH EMAIL AND STATED THAT AN ABDOMINAL X-RAY WAS PERFORMED AND OBSERVED TWO RODS. ON THE RECENT KIDNEY, URETER AND BLADDER ULTRASOUND, THE RADIOLOGIST STATED THAT THE CAPSULE APPEARED TO BE SEPARATED AND SOME OF IT WAS LODGED IN THE GASTROESOPHAGEAL JUNCTION WHILE OTHER BITS OF IT WERE IN THE COLON. THE PATIENT WAS FEELING BETTER.

  Patient problems: Abdominal Pain; Radiation Exposure, Unintended

  MAUDE report 7620093 ↗
• InjuryApr 17, 2018Entrapment of Device; Entrapment of Device

  ACCORDING TO THE REPORTER, THE CAPSULE HAS NOT DISSOLVED AFTER 48 HOURS OF INGESTION. ACCOUNT MANAGER ADVISED THAT PHYSICIAN PERFORMED X-RAYS AT 24 HOURS AND 48 HOURS AND CAPSULE HAS NOT DISSOLVED. THEY CONFIRMED THAT THE PATIENT WAS ASYMPTOMATIC AND TOLD THE PATIENT THAT IT COULD TAKE LONGER FOR THE CAPSULE TO DISSOLVE. PATIENT IS CURRENTLY STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7436861 ↗