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Recall Observatory FDA recall evidence

Device product

Olympus URETERO-RENO FIBERSCOPE Model: URF-P6R

Z-1264-2022

April 20, 2022

Class II

Product summary

Firm
Olympus Corporation of the Americas
Event
Event 90195
Status
Ongoing
Classification
Class II
Quantity
4 units
Official record key
device-enforcement:Z-1264-2022

Official wording

Reason: 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.

Code information: UDI-DI: 04953170340833 Serial Number: 2836209F 2835978 2837272 2836299

Distribution pattern: CA FL MA MD MI NJ OH PR WI

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.