SINGLE USE SPLINTING TUBE ST-SB1Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 04953170237201), received between Mar 8, 2022 and Oct 27, 2025 — classified as 13 injuries, 1 malfunction.

The most frequently reported specific device problem is “Inflation Problem” (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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryOct 27, 2025Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.

  Patient problems: Failure of Implant; Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 23391294 ↗
• InjuryOct 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO ADDITIONAL INFORMATION INFORMATION RECEIVED FROM THE CUSTOMER.

  Patient problems: Bowel Perforation

  MAUDE report 23375101 ↗
• InjuryOct 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) REVIEWED THE LITERATURE TITLED " COMPLICATIONS OF SINGLE-BALLOON ENTEROSCOPY: A NINE-YEAR MULTICENTER EXPERIENCE OF 2865 PROCEDURES". LITERATURE SUMMARY: BACKGROUND SINGLE-BALLOON ENTEROSCOPY (SBE) IS AN ESTABLISHED PROCEDURE FOR EVALUATING SMALL BOWEL LESIONS. WHILE ITS EFFICACY IS WELL RECOGNIZED, THE INCIDENCE OF MAJOR COMPLICATIONS AND THEIR ASSOCIATED RISK FACTORS IN A LARGE POPULATION REMAIN UNCLEAR. AIM TO INVESTIGATE THE COMPLICATIONS AND RISK FACTORS ASSOCIATED WITH DIAGNOSTIC SBE. METHODS THIS MULTICENTER RETROSPECTIVE STUDY INCLUDED CONSECUTIVE PATIENTS WHO UNDERWENT DIAGNOSTIC SBE AT THREE TERTIARY CARE HOSPITALS BETWEEN JANUARY 2016 AND SEPTEMBER 2024. DATA ON BASELINE CHARACTERISTICS, PROCEDURAL PARAMETERS, INDICATIONS, FINDINGS, AND MAJOR COMPLICATIONS WERE COLLECTED AND ANALYZED. RESULTS A TOTAL OF 2865 SBE PROCEDURES WERE PERFORMED IN 1840 PATIENTS. THE MEAN AGE WAS 51 ± 18 YEARS, AND 64.5% WERE MALE. THE MOST COMMON INDICATION WAS OB ULLAH S ET AL. COMPLICATIONS OF SBE WJG HTTPS://WWW.WJGNET.COM 2 SEPTEMBER 14, 2025 VOLUME 31 ISSUE 34 SCURE GASTROINTESTINAL BLEEDING (57.1%), FOLLOWED BY ABDOMINAL PAIN (30.5%). THE MAJOR COMPLIC

  Patient problems: Bowel Perforation

  MAUDE report 23373622 ↗
• InjuryOct 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO ADDITIONAL INFORMATION WAS RECEIVED FROM THE AUTHOR.

  Patient problems: Bowel Perforation

  MAUDE report 23373178 ↗
• InjuryOct 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO ADDITIONAL INFORMATION INFORMATION RECEIVED FROM THE CUSTOMER.

  Patient problems: Bowel Perforation

  MAUDE report 23372621 ↗
• InjuryOct 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO ADDITIONAL INFORMATION INFORMATION RECEIVED FROM THE CUSTOMER.

  Patient problems: Bowel Perforation

  MAUDE report 23372542 ↗
• InjuryOct 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO ADDITIONAL INFORMATION WAS RECEIVED FROM THE AUTHOR.

  Patient problems: Bowel Perforation

  MAUDE report 23372492 ↗
• InjuryOct 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO ADDITIONAL INFORMATION INFORMATION RECEIVED FROM THE CUSTOMER.

  Patient problems: Bowel Perforation

  MAUDE report 23372447 ↗
• InjuryOct 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED, "EFFICACY AND LONG-TERM OUTCOMES OF SINGLE-BALLOON ENTEROSCOPY-ASSISTED TREATMENT FOR BILIARY OBSTRUCTION AFTER CHOLEDOCHOJEJUNOSTOMY." LITERATURE SUMMARY: BACKGROUND: TO EVALUATE THE LONG-TERM EFFICACY OF SINGLE-BALLOON ENTEROSCOPY ENDOSCOPIC RETROGRADE CHOLANGIOGRAPHY (SBEERC) FOR THE TREATMENT OF BILIARY OBSTRUCTION AND TO ANALYZE THE FACTORS AFFECTING THE RECURRENCE OF BENIGN BILIOENTERIC ANASTOMOTIC STRICTURE AFTER SBE-ERC TREATMENT. METHODS: THE CLINICAL DATA OF PATIENTS WITH BILIARY DISEASES TREATED WITH SBE-ERC AFTER CHOLEDOCHOJEJUNOSTOMY IN OUR HOSPITAL FROM (B)(6) 2015 TO (B)(6) 2021 WERE ANALYZED RETROSPECTIVELY FOR THE SUCCESS RATES OF DIAGNOSIS AND TREATMENT AND THE INCIDENCE OF COMPLICATIONS. PATIENTS WHO WERE DIAGNOSED WITH BENIGN BILIOENTERIC ANASTOMOTIC STRICTURE WERE FOLLOWED UP. THE INDEPENDENT FACTORS AFFECTING RECURRENCE WERE OBTAINED BY UNIVARIATE AND MULTIVARIATE ANALYSES USING THE KAPLAN MEIER METHOD AND COX PROPORTIONAL HAZARD REGRESSION MODEL. RESULTS: A TOTAL OF (B)(4) SBE-ERCS WERE PERFORMED IN (B)(4) PATIENTS. THE OVERALL SUCCESS RATE WAS (B)(4)). THE INCIDENCE OF POSTOPERATIVE COMPLICATIONS WAS (B)(4).

  Patient problems: Abdominal Pain; Bowel Perforation; Chills; Cholangitis; Fever; High White Blood Cell Count

  MAUDE report 20375643 ↗
• MalfunctionMar 22, 2024Inflation Problem; Inflation Problem

  IT WAS REPORTED AT THE END OF A DIAGNOSTIC UPPER ENTEROSCOPY FOR ANEMIA, THE SPLINTING TUBE HAD AN INFLATION PROBLEM, ABNORMAL PRESSURE WAS OBSERVED. IT PROVIDED A NEGATIVE 2 AND A DEFLATED BALLOON BUT WHEN THE HOSE WAS REMOVED, THE BALLOON WAS STILL INFLATED RESULTING IN MINIMAL MUCOSAL EROSION. THERE WAS NO DELAY AND PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. THERE WERE NO REPORTS OF SERIOUS INJURY.

  Patient problems: Erosion

  MAUDE report 18962339 ↗
• InjuryJun 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT IS REPORTED IN THE LITERATURE TITLED: "SINGLE BALLOON ENTEROSCOPY: IS IT FEASIBLE? PATIENTS EXPERIENCED ADVERSE EVENTS AFTER PROCEDURES USING OLYMPUS DEVICES. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS OBCU. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS ST-SB1. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS SIF-Q260. BACKGROUND/AIMS. CURRENTLY, TWO ENDOSCOPIC MODALITIES ARE USED TO INVESTIGATE THE SMALL INTESTINE. CAPSULE ENDOSCOPY (CE) HAS BEEN USED MAINLY AS A SCREENING TOOL FOR EVALUATING OBSCURE GASTROINTESTINAL BLEEDING. HOWEVER, CE ALSO HAS SEVERAL DISADVANTAGES, SUCH AS INADEQUATE MANIPULATION IN THE LUMEN, THE INABILITY TO TAKE TISSUE SAMPLES, AND THE INABILITY TO TREAT INTESTINAL STRICTURES. DOUBLE-BALLOON ENTEROSCOPY (DBE) AND ITS INSERTION TECHNIQUE WERE FIRST PUBLISHED BY YAMAMOTO AND COWORKERS IN 2001. ALTHOUGH DBE IS MORE INVASIVE THAN CE, DBE IS CLINICALLY A VERY USEFUL TOOL NOT ONLY FOR DIAGNOSIS, BUT ALSO FOR ENDOSCOPIC THERAPY IN THE SMALL INTESTINE.5-15 ALTHOUGH THE METHOD FOR DBE INSERTION HAS ALREADY BEEN ESTABLISHED, THERE ARE A FEW PROBLEMS IN TERMS OF PREPARATION AND INSERTION FOR DBE AS COMPARED WITH CONVENTIONAL ENDOSCOPIES. FOR EXAMPLE, DURING PREPARATION,

  Patient problems: Fever; Peritonitis; Unspecified Tissue Injury

  MAUDE report 14848600 ↗
• InjuryJun 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT IS REPORTED IN THE LITERATURE TITLED ¿IMPACT OF SCOPE EXCHANGE FROM A LONG SINGLE BALLOON ENTEROSCOPE TO A GASTROSCOPE DURING ENTEROSCOPY-ASSISTED ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY IN PATIENTS WITH SURGICALLY ALTERED ANATOMY,¿ PATIENTS EXPERIENCED ADVERSE EFFECTS DURING OR AFTER PROCEDURES USING OLYMPUS DEVICES. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS GIF-CQ260. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS SIF-Q260. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS ST-SB1. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS OBCU. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS D-201-10704. BACKGROUND/AIMS: ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) IN PATIENTS WITH SURGICALLY ALTERED ANATOMY (SAA) IS CHALLENGING TO GASTROINTESTINAL ENDOSCOPISTS. THE AIM OF THIS STUDY WAS TO EVALUATE THE IMPACT OF SCOPE EXCHANGE FROM A LONG SINGLE BALLOON ENTEROSCOPE (SBE) TO A GASTROSCOPE DURING SBE-ASSISTED ERCP (SBE-ERCP) IN PATIENTS WITH SAA. METHODS: PATIENTS WHO UNDERWENT SBE-ERCP BETWEEN FEBRUARY 2019 AND OCTOBER 2020 WERE RETROSPECTIVELY IDENTIFIED. INTUBATION SUCCESS, SCOPE EXCHANGE SUCCESS, CANNULATION SUCCESS, AND THERAPEUTIC SUCCESS WERE ANALYZED ALONG WITH COMPLICATIONS. RES

  Patient problems: Perforation

  MAUDE report 14760289 ↗
• InjuryApr 5, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS PROVIDED BY THE AUTHOR: IN THE OPINION OF THE AUTHOR THE ADVERSE EVENTS WERE NOT ATTRIBUTED TO THE OLYMPUS DEVICE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Laceration(s)

  MAUDE report 14014166 ↗
• InjuryMar 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "MANAGEMENT OF DUODENAL-JEJUNAL POLYPS IN CHILDREN WITH PEUTZ-JEGHERS SYNDROME WITH SINGLE-BALLOON ENTEROSCOPY" BY BARBARA BIZZARRI, YOSVALDO BORRELLI, NICOLA DE¿ANGELIS ET AL. THIS SINGLE-CENTER PROSPECTIVE STUDY WAS AIMED TO ASSESS THE EFFICACY AND THE SAFETY OF SINGLE-BALLOON ENTEROSCOPY (SBE) FOR SMALL BOWEL POLYPS (>15 MM) IN CHILDREN AFFECTED WITH PEUTZ-JEGHERS SYNDROME (PJS). A TOTAL OF 10 10 CHILDREN WITH PJS WERE INCLUDED AND EVALUATED FOR FEASIBILITY, TECHNICAL PERFORMANCE, AND SAFETY. THE STUDY REVEALED THAT A TOTAL OF 16 PROCEDURES HAD AN ANTEROGRADE APPROACH, WHILE SEVEN HAD A RETROGRADE APPROACH, AND THE SBE WAS SUCCESSFUL IN ALL CHILDREN WITHOUT ANY TECHNICAL PROBLEMS. THE STUDY CLAIMED THAT NO ADVERSE EFFECTS WERE REPORTED EXCEPT MILD ABDOMINAL PAIN WAS REPORTED AFTER THREE PROCEDURES, AND POSTPOLYPECTOMY PERFORATION OCCURRED IN ONE PATIENT (4.3%), REQUIRING AN EMERGENCY LAPAROSCOPY WITH SURGICAL CLOSURE OF THE TEAR. THE PATIENT WAS DISCHARGED ONE WEEK AFTER SURGERY. THE STUDY CONCLUDED SBE IS AN EFFECTIVE AND ENDOSCOPIC TOOL FOR TREATING SMALL BOWEL POLYPS IN CHILDREN WITH PJS. FURTHERMORE, LARGE MULTICENTER STUDIES

  Patient problems: Perforation

  MAUDE report 13690423 ↗