EVIS EXERA COLONOVIDEOSCOPE OLYMPUS CF TYPE 2T160L (UDI 04953170066986)Recalls & reported problems

All models of EVIS EXERA COLONOVIDEOSCOPE (5)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports: 2
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04953170066986), received between Jul 12, 2023 and Jun 16, 2026 — classified as 2 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.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Failure to Clean Adequately2

Patient problems

No Clinical Signs, Symptoms or Conditions2

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

MalfunctionJun 16, 2026Failure to Clean Adequately
THE CUSTOMER RETURNED THE COLONOVIDEOSCOPE TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING THE DEVICE ANALYSIS, THE SERVICE REPORT TECHNICIAN INDICATES THAT WHITE FOREIGN OBJECT IN AIR WATER TUBE AND CYLINDER WAS FOUND. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25522241 ↗
MalfunctionJul 12, 2023Failure to Clean Adequately; Failure to Clean Adequately
THE EVIS EXERA COLONOVIDEOSCOPE WAS RETURNED TO AN OLYMPUS SERVICE CENTER FOR ANNUAL MAINTENANCE WITH NO COMPLAINT REPORTED BY THE END USER. DURING INSPECTION, IT WAS DISCOVERED THERE WAS FOREIGN MATTER FOUND WITHIN THE NOZZLE. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS BEING SUBMITTED FOR THE MALFUNCTION FOUND DURING THE DEVICE EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17307834 ↗

Device details

UDI-DI	`04953170066986`
Brand	EVIS EXERA COLONOVIDEOSCOPE
Model	OLYMPUS CF TYPE 2T160L
Company	Olympus Medical Systems Corp.
Product code	FET · Endoscopic video imaging system/component, gastroenterology-urology
Class	Class 2
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	No
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	Not in Commercial Distribution
Record updated	Jan 12, 2024

Device type (GMDN): Flexible video colonoscope, reusable

An endoscope with a flexible inserted portion intended for the visual examination and treatment of the entire colon [lower gastrointestinal (GI) tract]. It is inserted through the anus during colonoscopy. Anatomical images are transmitted to a monitor for viewing by a video system with a charge-coupled device (CCD) chip at the distal end of the endoscope. This device is commonly used to examine the lining of the colon or to evaluate altered bowel habits, colonic cancer, polyps, diverticular disease, occult or frank blood in stools, or unexplained anaemia. This is a reusable device.

Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

How reports and recalls are matched · Editorial policy · Report an error on this page