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

Model Number YC0507011

Device Problems Break (1069); Component Missing (2306)

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

Event Date 11/06/2018

Event Type  Injury  

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 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
• Type of Device: CANNULA+LUER+THREAD
• Manufacturer (Section D): SURGICAL INOVATIONS LTD; clayton wood house; 6 clayton wood bank; leeds, LS16 6QZ; UK LS16 6QZ
• Manufacturer (Section G): SURGICAL INNOVATIONS LTD; 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: 9806060
• MDR Text Key: 196396195
• Report Number: 9680952-2018-00074
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 05051986001364
• UDI-Public: 5051986001364
• 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: foreign,health professional
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 03/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Date Manufacturer Received: 11/09/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/12/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other