EVIS EXERA II COLONOVIDEOSCOPE OLYMPUS CF TYPE H180DLRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 04953170339653), received between Jun 20, 2018 and Jun 28, 2024 — classified as 2 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Failure to Clean Adequately” (6 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Sep 25, 2023Class IIOpen, Classified

   Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endoscopes has the potential for contamination that could lead to the risk of infection

   Z-0329-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 28, 2024Failure to Clean Adequately; Failure to Clean Adequately

  IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE COLONOVIDEOSCOPE EXHIBITED FOREIGN MATERIAL IN THE JET TUBE AT THE DISTAL END. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19638296 ↗
• InjuryJan 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE LITERATURE TITLED, "ENDOSCOPIC FULL-THICKNESS RESECTION VERSUS ENDOSCOPIC SUBMUCOSAL DISSECTION FOR CHALLENGING COLORECTAL LESIONS: A RANDOMIZED TRIAL" THE PURPOSE OF THIS RETROSPECTIVE STUDY WAS TO DIRECTLY COMPARE ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) AND ENDOSCOPIC FULL-THICKNESS RESECTION (EFTR) FOR THE RESECTION OF CHALLENGING COLORECTAL LESIONS IN A RANDOMIZED TRIAL. 90 CONSECUTIVE PATIENTS WERE INCLUDED IN THE STUDY, EQUALLY REPRESENTING THE 3 CHALLENGING LESION TYPES. SUBGROUP ANALYSIS ACCORDING TO LESION TYPE: 1. LST-NG GROUP A. EFTR GROUP I. 2 PATIENTS PRESENTED WITH LATE BLEEDING AND WERE TREATED CONSERVATIVELY. B. ESD GROUP I. A SINGLE RECURRENCE WAS FOUND AND MANAGED SUCCESSFULLY WITH EFTR. 2. NONLIFTING GROUP A. EFTR GROUP. I. 2 PATIENTS PRESENTED WITH LOCAL RECURRENCE; BOTH WERE TREATED WITH STANDARD POLYPECTOMY. B. ESD GROUP. I. 2 PATIENTS HAD A PERFORATION DURING THE PROCEDURE AND WERE TREATED CONSERVATIVELY. 3. ADENOMA RELAPSE/RECURRENCE GROUP. A. EFTR GROUP. B. ESD GROUP. I. 1 PATIENT HAD A PERFORATION AND WAS TREATED CONSERVATIVELY. THIS MEDWATCH REPORT IS RELATED TO THE FOLLOWING PATIENT IDENTIFIERS: (B)(6): GIF-H290T. (B)(6): KD-655Q. (B)

  Patient problems: Bowel Perforation; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 18526447 ↗
• MalfunctionJan 10, 2024Failure to Clean Adequately; Failure to Clean Adequately

  A USER FACILITY RETURNED THE OLYMPUS ASSET, EVIS EXERA II COLONOVIDEOSCOPE, TO THE OLYMPUS SERVICE CENTER. UPON INSPECTION AND TESTING OF THE RETURNED DEVICE, IT WAS OBSERVED THAT THE JET TUBE WAS CLOGGED. THIS REPORT IS BEING SUBMITTED FOR THE REPORTABLE MALFUNCTION FOUND DURING EVALUATION. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18483950 ↗
• MalfunctionNov 20, 2023Failure to Clean Adequately; Failure to Clean Adequately

  THE LOANER DEVICE WAS SENT WITH NO COMPLAINT. DURING THE DEVICE EVALUATION, THE FOLLOWING REPORTABLE MALFUNCTIONS WERE FOUND: AIR/WATER TUBE AND CYLINDER WITH FOREIGN MATERIAL. THERE WERE NO REPORTS OF PATIENT HARM. THIS MEDICAL DEVICE REPORT (MDR) IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTION FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18177123 ↗
• MalfunctionSep 11, 2023Failure to Clean Adequately; Failure to Clean Adequately

  THE CUSTOMER RETURNED THE EVIS EXERA II COLONOVIDEOSCOPE WITH NO INFORMATION. THERE WAS NO REPORTED PATIENT HARM OR IMPACT DUE TO THIS EVENT. DURING DEVICE EVALUATION AT OLYMPUS, IT WAS FOUND THERE WAS A WHITE CRYSTALIZED FOREIGN MATERIAL RESEMBLING TRACES FROM A DRY SOLUTION IN THE AIR/WATER TUBE AND CYLINDER. THE REPORT IS BEING SUBMITTED DUE TO FOREIGN MATERIAL IN THE SCOPE FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17718659 ↗
• MalfunctionSep 8, 2023Failure to Clean Adequately; Failure to Clean Adequately

  THE CUSTOMER RETURNED THE EVIS EXERA II COLONOVIDEOSCOPE TO OLYMPUS FOR ROUTINE MAINTENANCE. DURING EVALUATION, FOREIGN MATERIAL WAS FOUND AT THE AIR/WATER TUBE AND AIR/WATER CYLINDER. THIS MEDICAL DEVICE REPORT (MDR) IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTION FOUND DURING EVALUATION. NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17712399 ↗
• MalfunctionJun 16, 2023Device Reprocessing Problem; Device Reprocessing Problem

  THE CUSTOMER REPORTED TO OLYMPUS THAT THE EVIS EXERA II COLONOVIDEOSCOPE NO AIR/ WATER FLOW, LENS WATER RINSING DOESN'T WORK. FAULT WITH BUTTER IN THE CONNECTOR (CONNECTION UNIT) DURING MAINTENANCE. DURING INSPECTION AND EVALUATION, WHITISH FOREIGN MATERIAL WAS FOUND INSIDE THE AUXILIARY CHANNEL. THERE WAS NO REPORT OF PATIENT HARM OR USER INJURY ASSOCIATED WITH THIS EVENT. THIS MEDICAL DEVICE REPORT (MDR) IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTIONS FOUND DURING INCOMING INSPECTION AND EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17148130 ↗
• MalfunctionApr 12, 2023Device Contamination with Chemical or Other Material; Failure to Clean Adequately; Device Contamination with Chemical or Other Material; Failure to Clean Adequately

  A CUSTOMER REPORTED TO OLYMPUS, THE EVIS EXERA II COLONVIDEOSCOPE HAD A SMALL PIECE OF OUTER EDGE OF A CLAMP CHANNEL FELL OFF. THERE WAS NO REPORT OF PATIENT HARM ASSOCIATED WITH THIS EVENT. DURING INCOMING INSPECTION, THE AUXILIARY CHANNEL WAS DISCOLORED WITH RESIDUE OF FOREIGN MATERIAL DUE TO INSUFFICIENT CLEANING. THIS MEDWATCH IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTION FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16728827 ↗
• InjuryJun 20, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS WAS INFORMED THAT DURING AN UNSPECIFIED PROCEDURE, A PATIENT'S COLON WAS PERFORATED. IT WAS REPORTED THAT THE PATIENT IS VERY SLIM AND THE EVENT OCCURRED DURING THE SCOPE'S ASCENSION UP THE COLON. THERE WAS NO BLEEDING OBSERVED. AN X-RAY WAS PERFORMED. THE PATIENT WAS SENT TO THE OR AND UNDERWENT A LAPAROTOMY TO CLOSE THE PERFORATION. THE INTENDED PROCEDURE WAS ABORTED. THE PATIENT WAS ADMITTED TO THE HOSPITAL AND DISCHARGED FIVE DAYS POST OP. IN ADDITION, THE USER FACILITY REPORTED THAT THERE WAS NO MALFUNCTION NOTED WITH THE DEVICE DURING OR POST PROCEDURE.

  Patient problems: Bowel Perforation

  MAUDE report 7623737 ↗