Olympus Corporation of the Americas: Olympus URETERO-RENO FIBERSCOPE Model: URF-P6

Is my product affected?

Olympus URETERO-RENO FIBERSCOPE Model: URF-P6

• UPC 04953170340802

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

What happened

Olympus Corporation of the Americas is recalling Olympus URETERO-RENO FIBERSCOPE Model URF-P6 units due to incorrect adhesive used to secure the diopter ring and nameplate ring. The defect may cause the diopter ring to become improperly connected, resulting in loss of the adjustment function. This can lead to a blurred field of vision during use and potential unintentional contact with the patient's body, or in rare cases, perforation of the urinary tract or renal pelvis.

Two units were distributed across California, Florida, Massachusetts, Maryland, Michigan, New Jersey, Ohio, Puerto Rico, and Wisconsin. The affected devices have serial numbers 2836210 and 2834747I (UDI-DI: 04953170340802). The recall record does not specify a remedy or required action 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: 2 units Lot/code info: UDI-DI: 04953170340802 Serial Number: 2836210 2834747I

Source

Official record: FDA (Device enforcement) ↗

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

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