MAUDE Adverse Event Report: SURGICAL INNOVATIONS YELLOPORT PLUS; 5 X 150 THREADED CANNULA

Model Number	YC0515010
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/22/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Following a most recent fda inspection, this incident is being retrospectively reported.A piece of the device fell into a patient and was not retrieved.A device evaluation could not be performed because the device was returned without a decontamination certificate and labelled as "unsteril".As such, the device was considered to be a biohazard.From the visual appearance of the device through the outer clear polymer wallet, it was evident that the device had been subjected to extensive usage.The device was manufactured in june 2009 and sold to the customer in (b)(4) 2009.Additional information was received from the customer stating/confirming that the device was purchased in 2009 & the device had been used about 500 times.The warranty period for reusable devices is 2 years.The device is in excess of 5 years old and exceeds the warranty period.The distributor has confirmed that there was no patient harm or death.The dhr review indicated that the device assembly and packaging adhered to the final inspection and release criteria.It is highly likely that the cause of the issue reported was as a result of extensive usage/repeated processing of the device over an extended period of time.
Event or Problem Description
A distributor reported an incident that occured at a hospital ((b)(6)).During surgery, a small part from the tip of a yelloport cannula broke off.

• Brand Name: YELLOPORT PLUS
• Common Device Name: 5 X 150 THREADED CANNULA
• Manufacturer (Section D): SURGICAL INNOVATIONS; clayton wood house; 6 clayton wood bank; leeds, LS16 6QZ; UK LS16 6QZ
• MDR Report Key: 7036505
• Report Number: 9680952-2017-00001
• Device Sequence Number: 13989478
• Product Code: GCJ
• UDI-Device Identifier: 05051986001975
• UDI-Public: 05051986001975
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K070712
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 11/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: YC0515010
• Device Catalogue Number: YC0515010
• Device Lot Number: 49690
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/22/2015
• Initial Report FDA Received Date: 11/16/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1