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	10/01/2019
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.It was reported that the echo 2 device would be returned for evaluation.When the package was opened it only contained the outer carton with no device present inside.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.Not returned.
Event or Problem Description
It was reported that on (b)(6) 2019 the bard ventralight st w/ echo 2 device was placed into the abdomen laparoscopically and the mesh detached from the structural positioner (frame).Both parts (frame and mesh) were removed from the patient and a new mesh product was inserted to complete the procedure.There was no impact or injury 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: 9278897
• Report Number: 1213643-2019-10590
• Device Sequence Number: 2388865
• 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: 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: HUDP1060
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2019
• Initial Date Received by Manufacturer: 10/08/2019
• 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
• Patient Age: 25 YR