MAUDE Adverse Event Report: SURGICAL INNOVATIONS LTD YELLOPORT PLUS; 5/10/12MM SWINGTOP & DUCKBILL VALVE

Model Number	YA512STSA
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/16/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Damage and tearing of the 12mm and 10mm seals on swingtop.From photograph of the device, parts of the blue 10mm and red 12mm seals are missing.
Additional Manufacturer Narrative
Please see attached investigation report for details.Review of submission reports on 20th oct 2021 indicated that the final report for this submission had not been successful.
Event or Problem Description
Damage and tearing of the 12mm and 10mm seals on swingtop.From photograph of the device, parts of the blue 10mm and red 12mm seals are missing.
Additional Manufacturer Narrative
Please see attached investigation report for details.Review of submission reports on 20th oct 2021 indicated that the final report for this submission had not been successful 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 successful.
Event or Problem Description
Damage and tearing of the 12mm and 10mm seals on swingtop.From photograph of the device, parts of the blue 10mm and red 12mm seals are missing.

• Brand Name: YELLOPORT PLUS
• Common Device Name: 5/10/12MM SWINGTOP & DUCKBILL VALVE
• Manufacturer (Section D): SURGICAL INNOVATIONS LTD; clayton wood house; 6 clayton wood bank; leeds, west yorkshire LS16 6QZ; UK LS16 6QZ
• MDR Report Key: 10612047
• Report Number: 9680952-2020-00031
• Device Sequence Number: 14151426
• Product Code: GCJ
• UDI-Device Identifier: 05051986004921
• UDI-Public: 5051986004921
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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: foreign,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Inspection
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/01/2020

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: 10/15/2022
• Device Model Number: YA512STSA
• Device Lot Number: 711792
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/20/2020
• Supplement Date Received by Manufacturer: 07/20/2020; 07/20/2020
• Initial Report FDA Received Date: 10/01/2020
• Supplement Report FDA Received Date: 10/20/2021; 10/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1