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.
What this means for you
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
- Hazard
- adhesive-failure
- vision-impairment
- tissue-perforation
- patient-contact-risk
Distribution
Distributed in 9 states:
- CA
- FL
- MA
- MD
- MI
- NJ
- OH
- PR
- WI
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