MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. VENTRALIGHT ST W/ ECHO 2; SURGICAL MESH

Catalog Number	5990011
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/28/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Per the instructions-for-use, provided with the device, after rolling the device the user is instructed to "grasp the leading edge of the device with an atraumatic grasper or grasping tool.Take care to grasp both mesh and frame material." in follow up it is reported that the surgeon rolls the mesh and grabs onto the echo frame only and not both mesh and frame as instructed in the instructions-for-use, prior to inserting the device down the 12 mm trocar.Grabbing only the echo frame and not both the mesh and frame, could cause the frame to detach from the mesh during deployment.The most probable root cause is determined to be use related.The sample evaluation confirms the mesh to be detached from the echo 2 frame as reported.The sample evaluation shows no manufacturing anomalies with the device.A review of the manufacturing records was performed and found that the lot was manufactured to specification.To date this is the only reported complaint for this production lot of (b)(4) units released for distribution in april, 2019.
Event or Problem Description
It was reported that on (b)(6) 2019, the positioning system of a ventralight st mesh echo 2, detached from the mesh when trying to place the mesh in the patient's abdomen.As reported, the surgeon completed the case by using "another product".There was no injury or impact to the patient.

• Brand Name: VENTRALIGHT ST W/ ECHO 2
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 100 crossings blvd.; warwick RI 02886
• MDR Report Key: 9278891
• Report Number: 1213643-2019-10591
• Device Sequence Number: 2157556
• Product Code: FTL
• UDI-Device Identifier: 00801741130977
• UDI-Public: (01)00801741130977
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K170294
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/28/2020
• Device Catalogue Number: 5990011
• Device Lot Number: HUDP1719
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/22/2019
• Initial Report FDA Received Date: 11/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1