MAUDE Adverse Event Report: SURGICAL INNOVATIONS LIMITED YELLOPORT PLUS; 5×95 YELLOPORT PLUS CANNULA LUER THREAD

Model Number	YC0509501
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/15/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Following a most recent fda inspection, this incident is being retrospectively reported.No evaluation performed as devices have not been returned to the manufacturer.Following a review of the device history record for lot 64390 (manufactured november 2012).It was found that all manufacture and assembly operations were completed according to specified requirements and the devices satisfactorily completed 100% final inspection.All devices from this batch (b)(4) have been sold to one customer only on december 2012.No other complaints have been received for this batch.The distributor has confirmed that the issue may have been caused due to misuse (email evidence available).The distributor has confirmed that there was no patient harm or death.
Event or Problem Description
A distributor reported a complaint to surgical innovations.The complaint details state, during a laparoscopic appendectomy surgery, a doctor found a break on top of the cannula (2 devices affected) after 30 minutes of the surgery.No patient harm or injury has been reported.A x-ray and ct scan were carried out to locate the missing piece however no piece was found.The distributor has confirmed that there was no patient harm or death.

• Brand Name: YELLOPORT PLUS
• Common Device Name: 5×95 YELLOPORT PLUS CANNULA LUER THREAD
• Manufacturer (Section D): SURGICAL INNOVATIONS LIMITED; clayton wood house; 6 clayton wood bank; leeds, west yorkshire LS16 6QZ; UK LS16 6QZ
• MDR Report Key: 7058925
• Report Number: 9680952-2017-00009
• Device Sequence Number: 10786626
• Product Code: GCJ
• UDI-Device Identifier: 05051986001388
• UDI-Public: 05051986001388
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 11/27/2017

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: YC0509501
• Device Catalogue Number: YC0509501
• Device Lot Number: 64390
• 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: 04/15/2016
• Initial Report FDA Received Date: 11/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1