MAUDE Adverse Event Report: Surgical Innovations Ltd YelloPort Plus; 5mm single use valve

Model Number	YA05VSS01
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/02/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Description: during the closure phase of the tapp procedure, a missing valve was noticed; a search for the missing part was conducted but it was not found within the abdominal cavity, and the abdomen was closed.The patient is to be kept under observation.The valve has been discarded.Combined equipment: forceps by storz.Confirmed: the valve was damaged during the surgery, and a part of the valve was missing.Also, the damaged valve was discarded in the hospital.Conclusion after investigation: based on previous complaint investigations, this failure mode has only been observed where instrument tips were slightly open during insertion and subsequently pushed through the valve, resulting in a tear.Given the consistency of this failure mechanism with previous investigations, the root cause is concluded to be user error during instrument insertion.Given the frequency of reported events over the previous 12 months, a capa will be raised to further investigate this issue and implement appropriate measures to prevent future occurrences.
Additional Manufacturer Narrative
The root cause is concluded to be user error during instrument insertion.

• Brand Name: YelloPort Plus
• Common Device Name: 5mm single use valve
• Manufacturer (Section D): Surgical Innovations Ltd; clayton wood house; 6 clayton wood bank; leeds, north yorkshire LS166 QZ; UK LS166QZ
• Manufacturer (Section G): Surgical Innovations Ltd; clayton wood house; 6 clayton wood bank; leeds, north yorkshire LS166 QZ; UK LS166QZ
• Manufacturer Contact: stephen seed ; clayton wood house; 6 clayton wood bank; leeds, north yorkshire LS166-QZ ; UK LS166QZ
• MDR Report Key: 50082146
• Report Number: 9680952-2026-00006
• Device Sequence Number: 13316762
• Product Code: GCJ
• UDI-Device Identifier: 05051986002347
• UDI-Public: 05051986002347
• Combination Product (Y/N): Y
• Initial Reporter Country: US
• PMA/510(K) Number: K070712
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date (Section B): 07/28/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: YA05VSS01
• Device Lot Number: 744055
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/13/2026
• Initial Report FDA Received Date: 07/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/20/2025
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown