EVIS EXERA II SMALL INTESTINAL VIDEOSCOPE OLYMPUS SIF TYPE Q180 (UDI 04953170242526)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 04953170242526), received between Mar 18, 2020 and Sep 10, 2024 — classified as 1 death, 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Failure to Clean Adequately” (2 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 10, 2024Failure to Clean Adequately; Failure to Clean Adequately

  IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE SMALL INTESTINAL VIDEOSCOPE EXHIBITED THE NOZZLE HAD FOREIGN OBJECTS. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20182727 ↗
• MalfunctionAug 21, 2024Failure to Clean Adequately; Failure to Clean Adequately

  THE USER FACILITY RETURNED A EVIS EXERA II SMALL INTESTINAL VIDEOSCOPE TO THE SERVICE CENTER. DURING INSPECTION OF THE RETURNED DEVICE, THE NOZZLE HAD FOREIGN OBJECTS. THE CUSTOMER DID NOT REPORT ANY PATIENT USER INJURY OR HARM REPORTED TO OLYMPUS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20018901 ↗
• MalfunctionJun 14, 2024Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THE EVIS EXERA II SMALL INTESTINAL VIDEOSCOPE GAS CAP LEFT ON DURING ETO STERILIZATION RESULTING IN EXTENSIVE DAMAGE. THE ISSUE OCCURRED DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19538707 ↗
• InjuryApr 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON MARCH 31, 2021, OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) RECEIVED THE LITERATURE TITLED "THE ROLE OF SINGLE-BALLOON COLONOSCOPY (SBC) FOR PATIENTS WITH PREVIOUS INCOMPLETE STANDARD COLONOSCOPY: IS IT WORTH DOING IT?". THIS STUDY WAS CONDUCTED ON THE SINGLE-BALLOON OVERTUBE-ASSISTED COLONOSCOPY FOR 100 PATIENTS FROM FEBRUARY 2008 TO OCTOBER 2014. IN THE LITERATURE, IT WAS REPORTED MUCOSAL DEFECT, SEVERE ABDOMINAL PAIN, AND HEMATOCHEZIA. THE MUCOSAL DEFECT AFTER THE POLYPECTOMY WAS SUCCESSFULLY CLOSED WITH HEMOCLIPS, AND THE PATIENT RECEIVED PROPHYLACTIC ANTIBIOTICS AND REMAINED ASYMPTOMATIC. ANOTHER PATIENT SUFFERED FROM SEVERE ABDOMINAL PAIN AND HEMATOCHEZIA AFTER A DIAGNOSTIC SBC WITHOUT INTERVENTION. COMPUTED TOMOGRAPHY RESULTS EXCLUDED PERFORATION. THIS OUTPATIENT WAS THEN ADMITTED FOR MEDICAL OBSERVATION AND WAS DISCHARGED HOME PAIN-FREE AFTER 4 DAYS. THEREFORE, OMSC ASSUMES THAT THE PATIENT SUFFERED FROM SEVERE ABDOMINAL PAIN AND HEMATOCHEZIA WAS AN ADVERSE EVENT TO SUBMIT DUE TO HOSPITALIZATION FOR MEDICAL OBSERVATION. BASED ON THE AVAILABLE INFORMATION, SPECIFIC INFORMATION ON THE SUBJECT DEVICE AND THE PATIENTS WERE NOT PROVIDED. THERE IS NO DESCRIPTION OF THE DEVICE'S MALFU

  Patient problems: Abdominal Pain; Melena; Unspecified Tissue Injury

  MAUDE report 11668524 ↗
• DeathMar 18, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS RECEIVED AN ARTICLE TITLED ¿INSERTION OF PERCUTANEOUS ENDOSCOPIC GASTROSTOMY TUBES WITH JEJUNAL EXTENSIONS USING THE ¿WEDGE¿ TECHNIQUE: A NOVEL METHOD TO PREVENT RETROGRADE TUBE MIGRATION INTO THE STOMACH¿. THERE WERE 17 PATIENTS ON THE STUDY. THE ARTICLE REPORTED THAT TWO ADVERSE EVENTS OCCURRED DUE TO PEG INSERTION ALTHOUGH NONE WERE RELATED TO THE JEJUNAL EXTENSION INSERTION ITSELF USING THE WEDGE TECHNIQUE. ONE FEMALE PATIENT DEVELOPED ASYMPTOMATIC PNEUMOPERITONEUM AFTER THE PROCEDURE. SHE WAS DISCHARGED 6 HOURS LATER WHEN A REPEAT ABDOMINAL X-RAY SHOWED RESOLUTION OF MOST OF THE FREE AIR. SHE REMAINED ASYMPTOMATIC UNTIL NOON THE FOLLOWING DAY WHEN SHE TOOK A NAP WITH HER HUSBAND, COUGHED ONCE, AND STOPPED BREATHING. RESUSCITATION WAS NOT PERFORMED, FOLLOWING THE PATIENT¿S PRIOR WISHES. AN AUTOPSY WAS OFFERED BUT DECLINED. THIS IS PATIENT 2 OF 2 ADVERSE EVENTS FOR THE SUBJECT STUDY.

  Patient problems: Death

  MAUDE report 9849898 ↗
• InjuryMar 18, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS RECEIVED AN ARTICLE TITLED ¿INSERTION OF PERCUTANEOUS ENDOSCOPIC GASTROSTOMY TUBES WITH JEJUNAL EXTENSIONS USING THE ¿WEDGE¿ TECHNIQUE: A NOVEL METHOD TO PREVENT RETROGRADE TUBE MIGRATION INTO THE STOMACH¿. THERE WERE 17 PATIENTS IN THE STUDY. THE ARTICLE REPORTED THAT TWO ADVERSE EVENTS OCCURRED DUE TO PEG INSERTION ALTHOUGH NONE WERE RELATED TO THE JEJUNAL EXTENSION INSERTION ITSELF USING THE WEDGE TECHNIQUE. ONE STUDY PATIENT HAD THE PEG TUBE PLACED BUT DEVELOPED AN AIR LEAK AROUND THE PEG AFTER INSERTION. THE PATIENT WAS SUBSEQUENTLY TAKEN BACK TO THE OPERATING ROOM WHERE AN ABERRANT LOOP OF MESENTERY WAS FOUND BETWEEN THE ABDOMINAL AND ANTERIOR GASTRIC WALL PREVENTING APPOSITION TO FORM THE GASTROSTOMY TRACT. THE PEGJ DEVICE WAS REMOVED, AND RE-INSERTED AFTER THE MESENTERY HAD BEEN RELOCATED, AND THE PATIENT RECOVERED FULLY. THIS REPORT IS FOR PATIENT 1 OF 2 FOR SUBJECT STUDY.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 9849786 ↗