MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. VENTRALIGHT ST W/ ECHO; SURGICAL MESH

Catalog Number 5955610

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Bowel Perforation (2668)

Event Date 02/18/2020

Event Type  Injury  

Manufacturer Narrative

Based on the information provided by the hospital, the patient was insufflated to a pressure of 8 which is less than the normal amount of 12 or higher, the port was placed extremely lateral to the midline and the surgeon did not put the introducer tool in under camera vision.The information as provided, indicates that the patient adverse event was due to a use related incident and not related to a malfunction of the device.Per the instructions-for-use the user should "deliver the device through the trocar under sufficient visualization of the device and the surrounding anatomy." a review of the manufacturing records was performed and found that the lot was manufactured to specification.Discarded.

Event Description

It was reported that on (b)(6) 2020 during a difficult laparoscopic hernia repair with a bard ventralight st w/ echo ps, they were expecting to repair one hernia but found there were many.The bard mesh was going to be used across the multiple hernias.It was reported that the obturator device (introducer tool provided with the echo ps) penetrated the bowel on mesh insertion.Due to contamination in the area the ventralight st mesh was removed and a phasix mesh was used for repair of the hernias.The surgeon then performed a bowl anastomosis.As reported the abdominal pressure gas was up to 8, when normally this is done at 12 or higher, the port was placed extremely lateral from the midline and the surgeon did not put the introducer tool in under camera vision.The hospital is investigating the event and have not claimed the device is at fault.

• Brand Name: VENTRALIGHT ST W/ ECHO
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 100 crossings blvd.; warwick RI 02886
• Manufacturer (Section G): BARD SHANNON LIMITED 3005636544; san geronimo industrial park; lot #1, road #3, km 79.7; humacao PR 00791
• Manufacturer Contact: laura sundberg ; 100 crossings blvd.; warwick, RI 02886 ; 4018258462
• MDR Report Key: 9801735
• MDR Text Key: 182525071
• Report Number: 1213643-2020-02154
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00801741031748
• UDI-Public: (01)00801741031748
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K122436
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/28/2020
• Device Catalogue Number: 5955610
• Device Lot Number: HUCT0871
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/18/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/28/2018
• 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): Life Threatening; Required Intervention