MAUDE Adverse Event Report: SURGICAL INOVATIONS LTD YELLOPORT PLUS; CANNULA+LUER+THREAD

Model Number	YC0507011
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/06/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Due to the implementation of a new quality/regulatory team at surgical innovations limited, a review of historic complaints was conducted during a process improvement exercise.It was determined that the conclusion not to report complaint (b)(4) to the appropriate competent authorities was incorrect.In order to maintain full transparency of the history of surgical innovations limited devices, it has been determined that this complaint should be reported to the appropriate competent authorities.
Event or Problem Description
The concerned product was used during procedure of abdominal wall scar hernia on november 6th, wednesday, without any issue.However, they realized that distal end of the cannula was broken and missing when they visually inspected the product after sterilization.They watched recorded video in order to find the missing part and confirmed it was dropped inside the patient during procedure.To retrieve the missing part, second laparoscopic operation was made.Since the missing part was difficult to find, they switched the operation to open surgery and made 10cm surgical incision was made in the wall of the abdomen.

• Brand Name: YELLOPORT PLUS
• Common Device Name: CANNULA+LUER+THREAD
• Manufacturer (Section D): SURGICAL INOVATIONS LTD; clayton wood house; 6 clayton wood bank; leeds, LS16 6QZ; UK LS16 6QZ
• MDR Report Key: 9806060
• Report Number: 9680952-2018-00074
• Device Sequence Number: 2770002
• Product Code: GCJ
• UDI-Device Identifier: 05051986001364
• UDI-Public: 5051986001364
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K070712
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date (Section B): 03/09/2020

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?: No
• Operator of Device: Health Professional
• Device Model Number: YC0507011
• Device Lot Number: 712891
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/09/2018
• Initial Report FDA Received Date: 03/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other