ENDOCAPSULE SMALL INTESTINAL CAPSULE ENDOSCOPE SET MAJ-2027Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04953170328268), received between Jan 7, 2019 and May 1, 2023 — classified as 5 injuries.

The most frequently reported specific device problem is “Difficult to Remove” (1 report).

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryMay 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED, "FEASIBILITY AND DIAGNOSTIC YIELD OF SMALL-BOWEL CAPSULE ENDOSCOPY IN PATIENTS WITH SURGICALLY ALTERED GASTRIC ANATOMY: THE SAGA STUDY." BACKGROUND: LITTLE IS KNOWN ABOUT SMALL-BOWEL (SB) CAPSULE ENDOSCOPY (CE) IN PATIENTS WITH A HISTORY OF GASTRIC SURGERY. THIS STUDY AIMS TO EVALUATE THE FEASIBILITY AND DIAGNOSTIC YIELD (DY) OF ORALLY INGESTED SB-CE IN PATIENTS WITH SURGICALLY ALTERED GASTRIC ANATOMY. METHODS: TWENTY-FOUR EUROPEAN CENTERS RETROSPECTIVELY IDENTIFIED PATIENTS WHO HAD SB-CE AFTER TOTAL OR SUBTOTAL GASTRECTOMY. THE PRIMARY OUTCOME WAS THE DY OF SB-CE (INTERMEDIATE P1 TO HIGHLY P2 RELEVANT FINDINGS). SECONDARY OUTCOMES WERE GASTRIC AND SB TRANSIT TIMES, COMPLETION, CLEANLINESS, AND ADVERSE EVENT RATES. RESULTS: STUDIED WERE 248 PROCEDURES FROM 243 PATIENTS (MEAN AGE, 62 YEARS) WITH A HISTORY OF PARTIAL GASTRECTOMY (BILLROTH I, 13.1%; BILLROTH II, 34.6%), TOTAL GASTRECTOMY (7.4%), WHIPPLE PROCEDURE (12.8%), SLEEVE GASTRECTOMY (7.2%), OR GASTRIC BYPASS SURGERY (24.7%). OBSCURE GI BLEEDING WAS THE MOST FREQUENT INDICATION (85.1%). SB COMPLETION RATE WAS 84.3%. ONE CAPSULE RETENTION IN THE SB WAS NOTED (ADVERSE EVENT RATE,

  Patient problems: Unspecified Gastrointestinal Problem

  MAUDE report 16850267 ↗
• InjuryAug 3, 2022Difficult to Remove; Adverse Event Without Identified Device or Use Problem; Difficult to Remove; Adverse Event Without Identified Device or Use Problem

  IT IS REPORTED IN THE LITERATURE TITLED "SMALL BOWEL CAPSULE ENDOSCOPY IN THE MANAGEMENT OF ESTABLISHED CROHN¿S DISEASE: CLINICAL IMPACT, SAFETY, AND CORRELATION WITH INFLAMMATORY BIOMARKERS," USING ENDOCAPSULE, PATIENTS EXPERIENCED CAPSULE RETENTION. BACKGROUND: MULTIPLE STUDIES HAVE ESTABLISHED THE SUPERIOR DIAGNOSTIC ACCURACY OF VIDEO CAPSULE ENDOSCOPY (VCE) FOR THE DIAGNOSIS OF SMALL BOWEL (SB) CROHN¿S DISEASE (CD). HOWEVER, DATA ON THE CLINICAL IMPACT OF VCE IN PATIENTS WITH ESTABLISHED CD ARE SCARCE. THE AIM OF THIS STUDY WAS TO EXAMINE THE IMPACT AND SAFETY OF VCE ON THE CLINICAL MANAGEMENT OF PATIENTS WITH ESTABLISHED CD. METHODS: A RETROSPECTIVE, MULTICENTER, CROSS-SECTIONAL STUDY. THE STUDY COHORT INCLUDED CONSECUTIVE PATIENTS WITH ESTABLISHED SB CD WHO UNDERWENT VCE IN 4 TERTIARY REFERRAL CENTERS (1 CANADA, 1 SWEDEN, AND 2 UNITED KINGDOM) FROM JANUARY 2008 TO OCTOBER 2013. PATIENTS WERE EXCLUDED IF VCE WAS PERFORMED AS A PART OF THE INITIAL DIAGNOSTIC WORKUP. THE PRESENCE OF SB MUCOSAL INFLAMMATION WAS QUANTIFIED USING THE LEWIS SCORE. INFLAMMATORY BIOMARKERS (C-REACTIVE PROTEIN AND FECAL CALPROTECTIN) WERE MEASURED AND CORRELATED WITH THE LEWIS SCORE. RESULTS: THE STUDY

  Patient problems: Foreign Body In Patient

  MAUDE report 15156386 ↗
• InjuryMay 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER PROVIDED ADDITIONAL INFORMATION: THE INDICATION FOR THE ENDOCAPSULE PROCEDURE WAS IRON DEFICIENCY PRESUMED SECONDARY TO GASTROINTESTINAL BLOOD LOSS. THE PATIENT DID NOT UNDERGO ANY MEDICAL TREATMENT DURING THE EMERGENCY ROOM VISIT. THE PATIENT'S STATUS IS REPORTED AS "BETTER". THE CUSTOMER SUBMITTED MW5109760 TO THE FDA: I HAVE A CONTACT ALLERGY TO IODOPROPYNYL BUTYLCARBAMATE, A PRESERVATIVE FOUND IN A LOT OF MEDICAL SUPPLIES AND EQUIPMENT. IT CAUSES WATER BLISTERS, SEVERE REDNESS AND INFLAMMATION, BURNING AND CONSTANT PAIN/SKIN SENSITIVITY. I HAVE BEEN ADVISED THE DOCTOR FILED AN FDA REPORTED. BASED ON THE SYMPTOMS I AM HAVING, I AM 90% SURE THAT THE LINING OF MY INTESTINES/COLON IS EXPERIENCING THE SAME SYMPTOMS I HAVE EXPERIENCED ON MY SKIN. MY STOMACH FEELS RAW; MY STOMACH IS BURNING AND HURTING SEVERELY AND CONSTANTLY (FOR 3 WEEKS). THE ALLERGIC REACTION HAS BEEN TREATED WITH TOPICAL OINTMENT (BETAMETHASONE) IN THE PAST. MY LAST EPISODE, FALL 2021, WAS FROM A METAL SPLINT ON MY RING FINGER, LEFT HAND DUE TO A TORN TENDON. IT TOOK FIVE (5) MONTHS FOR THE SKIN TO HEAL. IN 2019, AT LUNG SURGERY, I HAD BACK SORES FROM 3M BRAND SURGICAL TAPE. I STILL HAVE MARKS ON MY B

  Patient problems: Foreign Body Reaction

  MAUDE report 14465838 ↗
• InjuryMay 20, 2022Unexpected Therapeutic Results

  THE PHYSICIAN AND PATIENT INFORMED OLYMPUS, THE PATIENT HAD THE SUBJECT DEVICE PROCEDURE "A FEW MONTHS BACK" AND HAVING SOME ISSUES. THE PHYSICIAN REPORTED THE PATIENT IS REPORTING STOMACH BURN. THE PATIENT REPORTED SHE IS ALLERGIC TO IODOTROTYNYL BUTYLCARBAMATE AND THINKS SHE IS HAVING A REACTION TO THE SUBJECT DEVICE. SHE IS HAVING ALLERGIC BLISTERS, REDNESS, INFLAMMATION, AND SHE IS IN PAIN. SHE WENT TO THE EMERGENCY ROOM AFTER TWO DAYS OF A BURNING STOMACH PAIN AND DIARRHEA. SHE STATES HER STOMACH IS "ON FIRE AND ACHING 24/7." THE PATIENT STATES SHE HAS LOST 11 POUNDS SINCE THIS STARTED. THE PATIENT REPORTED THE ENDOCAPSULE HAS BEEN INSIDE OF HER FOR AT LEAST 18 DAYS. SHE HAD X-RAY IMAGING DONE ON (B)(6) 2022 AND THE SUBJECT DEVICE WAS CONFIRMED IN THE PATIENT. ON (B)(6) 2022, THE PATIENT HAD ANOTHER X-RAY IMAGE AND IT CONFIRMED THE SUBJECT DEVICE HAD PASSED AND NO LONGER INSIDE THE PATIENT.

  Patient problems: Blister; Burning Sensation; Caustic/Chemical Burns; Erythema; Hypersensitivity/Allergic reaction; Inflammation; Pain; Weight Changes

  MAUDE report 14464412 ↗
• InjuryJan 7, 2019Entrapment of Device; Entrapment of Device

  OLYMPUS WAS INFORMED THAT A PATIENT UNDERWENT AN ENDOCAPSULE INTERNAL EXAMINATION ON (B)(6) 2017, AND THAT THE ENDOCAPSULE DEVICE WAS STILL IN THE PATIENT WHEN THE USER FACILITY CONTACTED OLYMPUS ON DEC. 12, 2018 TO INQUIRE ABOUT MRI COMPATIBILITY WITH THE DEVICE. IT WAS REPORTED THAT THE PATIENT HAD X-RAYS IN (B)(6), (B)(6) AND (B)(6) 2018 ALL CONFIRMING THE CONTINUED PRESENCE OF THE DEVICE INSIDE THE PATIENT. IT WAS ALSO REPORTED THAT THE USER FACILITY NOW PLANS TO REMOVE THE DEVICE FROM THE PATIENT BEFORE ATTEMPTING MRI ON THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY RESULTING FROM THE RETAINED DEVICE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8224708 ↗