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

Model Number YC0515010

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/22/2015

Event Type  malfunction  

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 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
• Type of Device: 5 X 150 THREADED CANNULA
• Manufacturer (Section D): SURGICAL INNOVATIONS; clayton wood house; 6 clayton wood bank; leeds, LS16 6QZ; UK LS16 6QZ
• Manufacturer (Section G): SURGICAL INNOVATIONS LIMITED; clayton wood house; 6 clayton wood bank; leeds, LS16 6QZ; UK LS16 6QZ
• Manufacturer Contact: sajid rafiq ; clayton wood house; 6 clayton wood bank; leeds, LS16 -6QZ ; UK LS16 6QZ
• MDR Report Key: 7036505
• MDR Text Key: 93201936
• Report Number: 9680952-2017-00001
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 05051986001975
• UDI-Public: 05051986001975
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K070712
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 11/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: YC0515010
• Device Catalogue Number: YC0515010
• Device Lot Number: 49690
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/22/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/12/2009
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1