EVIS EXERA SIGMOIDOVIDEOSCOPE OLYMPUS CF TYPE Q160S (UDI 04953170307669)Recalls & reported problems

All models of EVIS EXERA SIGMOIDOVIDEOSCOPE (3)

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

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports: 1
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 1

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04953170307669), received between Feb 25, 2026 and Feb 25, 2026 — classified as 1 malfunction.

The most frequently reported specific device problem is “Microbial Contamination of Device” (1 report).

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.

Reports received per month

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

Recalls naming this device

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

Device problems

Microbial Contamination of Device1

Patient problems

No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

MalfunctionFeb 25, 2026Microbial Contamination of Device
IT WAS REPORTED THAT, DURING REPROCESSING, THE SIGMOIDOVIDEOSCOPE TESTED POSITIVE FOR >50 COLONY FORMING UNITS (CFUS) OF PSEUDOMONAS AERUGINOSA, 18 COLONY FORMING UNITS (CFUS) OF ACINETOBACTER SPECIES, AND 2 COLONY FORMING UNITS (CFUS) OF GRAM-NEGATIVE ROD. ALL CHANNELS WERE SAMPLED. THE USER DID NOT REPORT ANY CONTAMINATION OR ANY OTHER SERIOUS DETERIORATION IN STATE OF HEALTH OF ANY PERSON, TO WHICH THE SCOPE COULD HAVE BEEN A CONTRIBUTORY CAUSE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24444814 ↗

Device details

UDI-DI	`04953170307669`
Brand	EVIS EXERA SIGMOIDOVIDEOSCOPE
Model	OLYMPUS CF TYPE Q160S
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 sigmoidoscope, reusable

An endoscope with a flexible inserted portion intended for the visual examination and treatment of the sigmoid colon (the distal S-shaped part of the large intestine leading to the rectum), typically in relation to altered bowel habit, colonic cancer, or polyps. It is inserted through the anus during sigmoidoscopy or proctosigmoidoscopy. Anatomical images are transmitted to the user by a video system with an image sensor chip at the distal end of the endoscope and the images showing on a monitor. 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 · each recall links to the FDA recall notice
Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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