Agency classClass IIOur severity:High FDA (Devices)·Z-1262-2022·Announced 2022-06-22

Olympus endoscope diopter ring adhesive failure may impair vision

Olympus endoscopes with defective diopter ring adhesive may cause vision loss and, in rare cases, urinary tract perforation.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II recall with potential for serious harm including rare urinary tract perforation, but no reported incidents. Fits rubric criterion of 'risk-of-harm products where injury has not yet been reported.'

Plain-English summary

Seven Olympus CYSTONEPHROFIBERSCOPE Model CYF-5 endoscopes have been recalled due to incorrect adhesive used to secure the diopter ring and nameplate ring. These devices are used for urinary and renal examination procedures.

The improper adhesive connection of the diopter ring may result in loss of the adjustment function, leading to a blurred field of vision during procedures. Additionally, the faulty adhesive may lead to unintended contact between the endoscope and the patient's body.

In rare cases, the defect may result in perforation of the urinary tract or renal pelvis. The recall affects devices distributed in California, Florida, Massachusetts, Maryland, Michigan, New Jersey, Ohio, Puerto Rico, and Wisconsin.

If you possess or use one of the affected devices, contact Olympus Corporation of the Americas immediately. The affected serial numbers are 2456630, 7171632, 2769732, W501648A, 2355088, 2557155, and 2972060.

The recalled product

Product: Olympus CYSTONEPHROFIBERSCOPE Model: CYF-5
Manufacturer: Olympus Corporation of the Americas
Category: Medical Device — Surgical Endoscope
Hazard: adhesive-failure
vision-impairment
tissue-perforation
patient-contact-risk
Affected units: 7

Distribution

Distributed in 9 states:

Part of a larger recall action

This product is one of 3 recalled by Olympus Corporation of the Americas under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

Same manufacturer · Olympus Corporation of the Americas

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