MAUDE Adverse Event Report: SURGICAL INNOVATIONS LTD YELLOPORT PLUS; YELLOPORT PLUS 5X70 CANNULA + LUER

Model Number	YC0507001
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/13/2022
Type of Reportable Event	Malfunction
Event or Problem Description
After receipt, the customer found that the device was labelled "sterile r", with a due date, and disposable symbol on the label despite non sterile device.
Event or Problem Description
After receipt, the customer found that the device was labelled "sterile r", with a due date, and disposable symbol on the label despite non sterile device.
Additional Manufacturer Narrative
Urgent field safety notice revised on 20th january to add an additional part number/lot number.Part number:: ea10nh.Description: hasson adaptor 10mm.Lot number: 734029.
Event or Problem Description
After receipt, the customer found that the device was labelled "sterile r", with a due date, and disposable symbol on the label despite non sterile device.
Additional Manufacturer Narrative
Urgent field safety notice revised on 20th january to add an additional part number/lot number.Part number:: ea10nh.Description: hasson adaptor 10mm.Lot number: 734029.Corrected to remove "5 day", first report type should have been 'initial' when first reported on 17th january 2022, and changed to follow up report 2.
Event or Problem Description
After receipt, the customer found that the device was labelled "sterile r", with a due date, and disposable symbol on the label despite non sterile device.
Event or Problem Description
After receipt, the customer found that the device was labelled "sterile r", with a due date, and disposable symbol on the label despite non sterile device.
Additional Manufacturer Narrative
Urgent field safety notice revised on 20th january to add an additional part number/lot number.Part number:: ea10nh; description: hasson adaptor 10mm; lot number: 734029.Revised urgent field safety notice is attached to this report.G6 reporting corrected to remove "5 day", first report type should have been 'initial' when first reported on 17th january2022, and changed to follow up report 2.Investigation report attached to this report.

• Brand Name: YELLOPORT PLUS
• Common Device Name: YELLOPORT PLUS 5X70 CANNULA + LUER
• Manufacturer (Section D): SURGICAL INNOVATIONS LTD; clayton wood house; 6 c;ayton wood bank; leeds, west yorkshire LS16 6QZ; UK LS16 6QZ
• Manufacturer (Section G): SURGICAL INNOVATIONS LTD; clayton wood house; clayton wood bank; leeds, wst yorkshire LS16 6QZ; UK LS16 6QZ
• Manufacturer Contact: stephen seed ; clayton wood house; clayton wood bank; leeds, west yorkshire LS16 -6QZ ; UK LS16 6QZ
• MDR Report Key: 13265034
• Report Number: 9680952-2022-00001
• Device Sequence Number: 6062000
• Product Code: GCJ
• UDI-Device Identifier: 05051986001890
• UDI-Public: 05051986001890
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K070712
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 02/02/2022

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: YC0507001
• Device Lot Number: 735652
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/13/2022
• Supplement Date Received by Manufacturer: 01/13/2022; 01/13/2022; 01/13/2022
• Initial Report FDA Received Date: 01/17/2022
• Supplement Report FDA Received Date: 02/02/2022; 02/25/2022; 03/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/13/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown