MAUDE Adverse Event Report: SURGICAL INNOVATIONS LIMITED YELLOPORT PLUS; YELLOPORT PLUS 5 X 55 THREADED CANNULA

Model Number	YC0505510
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/23/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Following a most recent fda inspection, this incident is being retrospectively reported.Assessment was performed by professor mcmahon to identify causes of cannula tip having broken with the main cause potentially being due to jaws of an instrument being prematurely opened while still within the cannula shaft.The dhr was reviewed for lot 64131 part number yc0505510 (manufactured july 2012) was reviewed.All assembly processes were completed according to specified requirements and all devices satisfactorily completed final inspection.The investigation has shown that the cause of the broken end was due to opening of jaws within the shaft of the cannula.The device is also over 4 years old, it is recommended the device is replaced every two years and the device subsequently has a two year warranty period.The breakage could be attributed to wear and tear over a prolonged period of time and over 200 autoclave cycles.The part that broke off was not recovered from the patient.The surgeon made a decision that there will be no problems and the missing part will eventually become capsuled by tissue within the body.According to the hospital ((b)(6)) the surgeon is very skilled with many years experience.
Event or Problem Description
A distributor reported that a yelloport plus cannula broke inside a patient during an operation.

• Brand Name: YELLOPORT PLUS
• Common Device Name: YELLOPORT PLUS 5 X 55 THREADED CANNULA
• Manufacturer (Section D): SURGICAL INNOVATIONS LIMITED; clayton wood house; 6 clayton wood bank; leeds, west yorkshire LS16 6QZ; UK LS16 6QZ
• MDR Report Key: 7057401
• Report Number: 9680952-2017-00004
• Device Sequence Number: 1461389
• Product Code: GCJ
• UDI-Device Identifier: 05051986001975
• UDI-Public: 05051986001975
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K070712
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 11/23/2017

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: YC0505510
• Device Catalogue Number: YC0505510
• Device Lot Number: 64131
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/26/2016
• Initial Report FDA Received Date: 11/24/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1