MAUDE Adverse Event Report: BARD SHANNON LIMITED VENTRALIGHT MESH ST 4.5" CIRCLE; MESH, SURGICAL, POLYMERIC

Model Number 5954450

Device Problem Defective Device (2588)

Patient Problem Unspecified Infection (1930)

Event Date 12/08/2021

Event Type  Injury  

Event Description

Return to surgery for infected mesh with phasix implantation, bowel obstructions and s/p explantation of infected ventralight mesh with phasix.According to the op note dated (b)(6) 2021.The proximal and distal limbs of intestine were then aligned with stay sutures so that a side-to-side stapled anastomosis could be performed at the antimesenteric border of the intestine.Ultimately a laparoscopic stapler was used to create the anastomosis as the robotic stapler had a malfunction preventing it from clamping.The opening in small bowel was closed in two layers using 2-0 v-lock in a running fashion.The mesenteric defect was also closed using the end of this suture.Also during the case on (b)(6) 2021, while in step trendelenburg and airplaned left, he slid on the table which required repositioning of him and the robot.Robotic stapler was sent to intuitive.

• Brand Name: VENTRALIGHT MESH ST 4.5" CIRCLE
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): BARD SHANNON LIMITED
• MDR Report Key: 13118139
• MDR Text Key: 283092976
• Report Number: MW5106364
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 12/27/2021
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/28/2023
• Device Model Number: 5954450
• Device Catalogue Number: 5954450
• Device Lot Number: HUFP09919
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 2-0 V-LOCK SUTURE
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Weight: 80 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White