Olympus Fiberscope Recalled for Defective Diopter Ring Adhesive
Olympus URETERO-RENO FIBERSCOPE Model URF-P6R recalled due to incorrect adhesive securing the diopter ring, which may cause loss of focus 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 medical device recall with potential for serious injury including rare perforation of the urinary tract. No illnesses or injuries have been reported. Classification reflects risk-of-harm to patients where injury has not yet been documented.
Plain-English summary
Olympus Corporation of the Americas is recalling the URETERO-RENO FIBERSCOPE Model URF-P6R due to an adhesive defect in the diopter ring. The diopter ring is the focus-adjustment component that enables clear visualization during endoscopic procedures.
Incorrect adhesive was used to secure the diopter ring and nameplate ring. If the diopter ring becomes improperly connected, the user may lose the ability to adjust focus, resulting in a blurred field of vision. An improperly functioning diopter ring can also lead to unintentional contact with the patient's body during the procedure, and in rare cases may result in perforation of the urinary tract or renal pelvis.
Four units of this device have been distributed to facilities in California, Florida, Massachusetts, Maryland, Michigan, New Jersey, Ohio, Puerto Rico, and Wisconsin.
Affected healthcare facilities should discontinue use of the recalled fiberscopes and contact Olympus Corporation of the Americas for instructions on repair, replacement, or return of the affected devices.
The recalled product
- Product
- Olympus URETERO-RENO FIBERSCOPE Model: URF-P6R
- Manufacturer
- Olympus Corporation of the Americas
- Hazard
- vision-impairment
- tissue-perforation
- improper-equipment-function
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI-DI: 04953170340833 Serial Number: 2836209F 2835978 2837272 2836299
Distribution
Distributed in 9 states:
- CA
- FL
- MA
- MD
- MI
- NJ
- OH
- PR
- WI
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