OES HYSTEROFIBERSCOPE OLYMPUS HYF TYPE 1T (UDI 04953170411090)Recalls & reported problems

Olympus Medical Systems Corp. · OES HYSTEROFIBERSCOPE · Class 2

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

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04953170411090), received between Jun 6, 2024 and Jun 6, 2024 — classified as 1 malfunction.

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

Reports received per month

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

Most reported problems

Device problems

Failure to Clean Adequately1

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.

MalfunctionJun 6, 2024Failure to Clean Adequately; Failure to Clean Adequately
IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE HYSTEROFIBERSCOPE EXHIBITED A FOREIGN OBJECT ON ACTUATOR BODY. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19480713 ↗

Device details

UDI-DI	`04953170411090`
Brand	OES HYSTEROFIBERSCOPE
Model	OLYMPUS HYF TYPE 1T
Company	Olympus Medical Systems Corp.
Product code	HIH · HYSTEROSCOPE (AND ACCESSORIES)
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	Apr 16, 2025

Device type (GMDN): Flexible fibreoptic hysteroscope

An endoscope with a flexible inserted portion intended for the visual examination and treatment of the canal of the cervix and the uterine cavity (uterus). It is inserted through the vagina during hysteroscopy. Anatomical images are transmitted to the user by the device through a fibreoptic bundle. Distention of the uterus with either liquid or carbon dioxide (CO2) gas may be used to improve viewing. This device is commonly used to evaluate/treat fibroids (myomas), polyps, or causes of severe cramping (dysmenorrhea), heavy menstrual periods (menorrhagia) and bleeding between periods (metrorrhagia). This is a reusable device.

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All HYSTEROSCOPE (AND ACCESSORIES) devices →

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.

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