Olympus Uretero-Reno Fiberscope Recalled for Defective Adhesive and Vision Loss
The Olympus URETERO-RENO FIBERSCOPE Model URF-P6 is recalled for incorrect adhesive securing the diopter ring. The defect may cause loss of adjustment function, blurred vision, 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 device with potential for serious injury (urinary tract perforation) but no reported illnesses or injuries. The hazard is characterized as occurring in rare cases, making it a risk-of-harm product where injury has not yet been reported.
Plain-English summary
The Olympus URETERO-RENO FIBERSCOPE Model URF-P6 is being recalled due to incorrect adhesive used to secure the diopter ring and nameplate ring. An improperly connected diopter ring can result in loss of the adjustment function.
When adjustment function is lost, the device may exhibit a blurred field of vision. This can lead to unintended contact between the scope and the patient's body. In rare cases, this may result in perforation of the urinary tract or renal pelvis.
Two units have been identified and are distributed across California, Florida, Massachusetts, Maryland, Michigan, New Jersey, Ohio, Puerto Rico, and Wisconsin.
The recalled product
- Product
- Olympus URETERO-RENO FIBERSCOPE Model: URF-P6
- Manufacturer
- Olympus Corporation of the Americas
- Hazard
- adhesive-defect
- vision-impairment
- unintended-contact
- perforation-risk
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: 04953170340802 Serial Number: 2836210 2834747I
Distribution
Distributed in 9 states:
- CA
- FL
- MA
- MD
- MI
- NJ
- OH
- PR
- WI
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