Olympus Corporation of the Americas: Olympus CYSTONEPHROFIBERSCOPE Model: CYF-5

Is my product affected?

Olympus CYSTONEPHROFIBERSCOPE Model: CYF-5

• UPC 04953170339417

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

What happened

Olympus Corporation of the Americas is recalling Olympus CYSTONEPHROFIBERSCOPE Model CYF-5 devices 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 adjustment function that leads to a blurred field of vision. This malfunction could cause unintended contact with a patient's body and, in rare cases, perforation in the urinary tract or renal pelvis.

Seven units were distributed across California, Florida, Massachusetts, Maryland, Michigan, New Jersey, Ohio, Puerto Rico, and Wisconsin. The affected devices can be identified by UDI-DI 04953170339417 and the following serial numbers: 2456630, 7171632, 2769732, W501648A, 2355088, 2557155, and 2972060. The source does not specify a remedy 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: 7 units Lot/code info: UDI-DI: 04953170339417 Serial Number: 2456630 7171632 2769732 W501648A 2355088 2557155 2972060

Source

Official record: FDA (Device enforcement) ↗

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

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