URF-P6 Uretero-reno fiberscope and URF-P6R Uretero-reno fiberscope
FDA Recall Z-1251-2017 · Posted None
Recalling FirmOlympus Corporation of the Americas
Recall StatusTerminated
Product CodeFBN
Date Initiated2016-12-12
Date Terminated2018-02-26
Product Quantity3461 units distributed to US consignees
Reason for Recall
Olympus is recalling the URF-P6/P6R endoscopes due to a similar device (URF-V2/V2R endoscopes) but not identical, where adverse event complaints associated with tissue trauma, perforation and insertion tubes which were stuck inside of patients that had to be surgically removed. In an effort to mitigate a potential risk to patient health, Olympus is undertaking this action to notify users of these complaints and the need for careful inspection of the endoscope prior to use in accordance with the instructions provided int heir notification letter.
Firm Action
Olympus sent an Urgent Medical Device Safety Notice dated December 29, 2016, to those that were affected by this issue. The letter addressed the corrective actions Olympus that were taken to address the issue. Consignees were asked to inspect their inventory for the specified device, review the enclosed Instructions for Safe Use, which provided instructions to assist with understanding the Warnings and Cautions.
You can contact our Technical Assistance Center (TAC) at 1-(800) 848-9024, option 1, to answer any questions.
Root Cause
Under Investigation by firm
Distribution Pattern
Distributed Nationwide
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.