MAUDE Adverse Event Report: SURGICAL INNOVATIONS LTD YELLOPORT PLUS; 5MM SINGLE USE DUCKBILL VALVE

Model Number	YA05VSS01
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/16/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Before the lap procedure, nurse opened the package as usual and checked the valve briefly.However, after the procedure completed, the nurse dissembled the reusable and disposable parts of trocar, she found there was missing portion on that valve and they couldn't find it anywhere.
Additional Manufacturer Narrative
Please see attached complaint investigation report for details update for this submission to note that the final report was submitted on the 30th november 2020 but was not identified until 20th october 2021 that the final submission report had not been sucessful.
Event or Problem Description
Before the lap procedure, nurse opened the package as usual and checked the valve briefly.However, after the procedure completed, the nurse dissembled the reusable and disposable parts of trocar, she found there was missing portion on that valve and they couldn't find it anywhere.

• Brand Name: YELLOPORT PLUS
• Common Device Name: 5MM SINGLE USE DUCKBILL VALVE
• Manufacturer (Section D): SURGICAL INNOVATIONS LTD; clayton wood house; 6 calyton wood bank; leeds, west yorkshire LS16 6QZ; UK LS16 6QZ
• MDR Report Key: 10710626
• Report Number: 9680952-2020-00041
• Device Sequence Number: 14299232
• Product Code: GCJ
• UDI-Device Identifier: 05051986002347
• UDI-Public: 05051986002347
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• 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,foreign,health pr
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date (Section B): 10/21/2020

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 Expiration Date: 03/15/2024
• Device Model Number: YA05VSS01
• Device Lot Number: 730585
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/21/2020
• Supplement Date Received by Manufacturer: 10/21/2020
• Initial Report FDA Received Date: 10/21/2020
• Supplement Report FDA Received Date: 10/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1