MAUDE Adverse Event Report: SURGICAL INNOVATIONS LIMITED YELLOPORT PLUS; YELLOPORT PLUS 5/10/12MM ARMOURED SWINGTOP

Model Number YA512STSA

Device Problems Component Missing (2306); Device Or Device Fragments Location Unknown (2590)

Patient Problem No Code Available (3191)

Event Date 02/01/2017

Event Type  malfunction  

Manufacturer Narrative

Following a most recent fda inspection, this incident is being retrospectively reported.The complaint sample was inspected by the quality department, the customer has returned a swingtop lot number 700029 only.Upon inspection of the device, a small section of the 10ml blue silicone valve is detached, a tear is visible and a small piece of the silicone valve is loose.There is no other damage present on the device.The device history record for lot number 700029 was reviewed on the 28th february 2017, (b)(4) units were manufactured in november 2015.From review of previous complaints of a similar nature and the investigations that have been carried out, it is possible the silicone may have been damaged by the use of an instrument that is larger than what the 10mm swingtop housing is designed to accommodate.It is also possible that no additional lubrication may have applied to the 10mm valve which has caused excessive friction resulting in the silicone to tear.Medical grade lubricant is applied to the valve of each device to allow the ease of introduction of devices, however it is recommended that sufficient lubrication is applied to any instrument shafts that are passed through the valves and that care is also taken when going through the valve, particularly when using sharp instruments.

Event Description

A distributor reported that a customer noticed a piece missing on a swingtop device after 3 hours of operation.The doctor used a 10mm stortz camera scope instrument with the device.An xray was carried out to locate the missing piece inside the patient, the piece was not found.

• Brand Name: YELLOPORT PLUS
• Type of Device: YELLOPORT PLUS 5/10/12MM ARMOURED SWINGTOP
• Manufacturer (Section D): SURGICAL INNOVATIONS LIMITED; clayton wood house; 6 clayton wood bank; leeds, west yorkshire LS16 6QZ; UK LS16 6QZ
• Manufacturer (Section G): SURGICAL INNOVATIONS LIMITED; clayton wood house; 6 clayton wood bank; leeds, west yorkshire LS16 6QZ; UK LS16 6QZ
• Manufacturer Contact: sajid rafiq ; clayton wood house; 6 clayton wood bank; leeds, west yorkshire LS16 -6QZ ; UK LS16 6QZ
• MDR Report Key: 7058435
• MDR Text Key: 93619268
• Report Number: 9680952-2017-00005
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 05051986006567
• UDI-Public: 05051986006567
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K070712
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 11/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2020
• Device Model Number: YA512STSA
• Device Catalogue Number: YA512STSA
• Device Lot Number: 700029
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/01/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/30/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1