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

Catalog Number	5955610
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Bowel Perforation (2668)
Date of Event	02/18/2020
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 100 crossings blvd.; warwick RI 02886
• MDR Report Key: 9801735
• Report Number: 1213643-2020-02154
• Device Sequence Number: 778473
• Product Code: FTL
• UDI-Device Identifier: 00801741031748
• UDI-Public: (01)00801741031748
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K122436
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/06/2020

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 Expiration Date: 06/28/2020
• Device Catalogue Number: 5955610
• Device Lot Number: HUCT0871
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/18/2020
• Initial Report FDA Received Date: 03/06/2020
• 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: Life Threatening; Required Intervention