Olympus Corporation of the Americas: Olympus URETERO-RENO FIBERSCOPE Model: URF-P6R

Is my product affected?

Olympus URETERO-RENO FIBERSCOPE Model: URF-P6R

• UPC 04953170340833

Check against the official notice below — it lists the full affected range.

What happened

Olympus Corporation of the Americas is recalling the Olympus URETERO-RENO FIBERSCOPE Model URF-P6R due to incorrect adhesive used to secure the diopter ring and nameplate ring. The defect may cause the diopter ring to become improperly connected, which could result in loss of the adjustment function and a blurred field of vision during use.

The potential consequence of the blurred vision is unintentional contact with the patient's body, and in rare cases, perforation of the urinary tract or renal pelvis. A total of 4 units with serial numbers 2836209F, 2835978, 2837272, and 2836299 were distributed across California, Florida, Massachusetts, Maryland, Michigan, New Jersey, Ohio, Puerto Rico, and Wisconsin. The recall record does not specify a remedy or instructions for affected consumers.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

Incorrect adhesive used to secure the diopter ring and nameplate ring. Improperly connected diopter ring may result in the loss of adjustment function leading to a blurred field of vision and unintentional contact with the patients body and in rare cases perforation in the urinary tract/renal pelvis.

Details from the source

Reason for recall: Incorrect adhesive used to secure the diopter ring and nameplate ring. Improperly connected diopter ring may result in the loss of adjustment function leading to a blurred field of vision and unintentional contact with the patients body and in rare cases perforation in the urinary tract/renal pelvis. Distribution: CA FL MA MD MI NJ OH PR WI Quantity: 4 units Lot/code info: UDI-DI: 04953170340833 Serial Number: 2836209F 2835978 2837272 2836299

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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