Recall Z-2519-2018

Reason for recall

Breakage of the endoscope's insertion tube bending section during surgical procedures.

FDA-determined cause: Device Design

Action taken

On 1/17/18 an Urgent Medical Device Removal Action Notification letter was shipped to affected customer via Fed-EX. The notification informed customers the recall was initiated in response to customer complaints regarding the breakage of the endoscopes insertion tube bending section during surgical procedures.Customers were instructed to complete the following: 1. Inspect your inventory and identify any URF-P6/P6R models; 2.Olympus will contact your facility to make arrangements for return of your URF-P6/P6R fiberscope(s) for the device exchange. You will be provided instructions on returning the URF-P6/P6R for this exchange; 3.Olympus has discontinued previously distributed copies of the URF-P6/P6R Reprocessing Manual and the Operation Manual Inspect your inventory of the Reprocessing Manual and the Operation Manual, and discard any existing inventory of the URF-P6/P6R Reprocessing Manual and the Operation Manual; 4.Implement use of the enclosed Reprocessing Manual which recommends only sterilization methods, and the enclosed Operation Manual; 5. Ensure all reprocessing personnel are completely knowledgeable and thoroughly trained on the new reprocessing instructions in the new Reprocessing Manual; 6. If you may have further distributed the URF-P6/P6R, please identify your customers, notify them at once of this product recall, and appropriately document your notification process. Your notification to your customers may be enhanced by including a copy of this recall notification letter; 7. Please indicate on the enclosed questionnaire that you have received this notification. Return of the enclosed questionnaire will be deemed to be a request for a new replacement URF-P6/P6R fiberscope(s). Fax the completed form to 484-896-7128.