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

Model Number YA05VSS01

Device Problems Break (1069); Melted (1385)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/09/2019

Event Type  malfunction  

Event Description

During surgery, a probe was inserted, and pulled out through ya05vss01 silicone valve, and our customer found the product was melted, and broken.

• Brand Name: YELLOPORT PLUS
• Type of Device: 5MM SINGLE USE DUCKBILL VALVE
• Manufacturer (Section D): SURGICAL INNOVATIONS LIMITED; clayton wood house; 6 clayton wood bank; leeds, LS16 6QZ; UK LS16 6QZ
• Manufacturer Contact: stephen seed ; clayton wood house; 6 clayton wood bank; leeds, LS16 -6QZ ; UK LS16 6QZ
• MDR Report Key: 9279092
• MDR Text Key: 216647693
• Report Number: 9680952-2019-00067
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 05051986002347
• UDI-Public: 05051986002347
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K070712
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 10/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/15/2024
• Device Model Number: YA05VSS01
• Device Lot Number: 730585
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/25/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/15/2019
• 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
• Patient Outcome(s): Other