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

Catalog Number	5991015
Medical Device Problem Codes	Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Codes	Injury (2348); Foreign Body In Patient (2687)
Date of Event	03/28/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the events as reported the echo 2 ps was not removed from the patient as prescribed in the instructions-for-use.The root cause is confirmed as use related with no malfunction of the device.The warning section of the instructions-for-use states: ventralight¿ st mesh is the only permanent implant component of the device.The echo 2¿ positioning system (which includes deployment frame, center hoisting suture and all connectors) must be removed from the patient and appropriately discarded.It is not part of the permanent implant.Sample not returned.
Event or Problem Description
It was reported that on (b)(6) 2019 the patient underwent a robotic assisted laparoscopic ventral incisional hernia repair with a ventralight st w/ echo 2 ps.The surgeon later realized he had not removed the echo 2 ps portion of the device from the implant.On (b)(6) 2019 the patient underwent a laparoscopic procedure for removal of the echo 2 ps.As reported the procedure was uncomplicated.

• Brand Name: VENTRALISHT 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: 8568633
• Report Number: 1213643-2019-03534
• Device Sequence Number: 14039804
• Product Code: FTL
• UDI-Device Identifier: 00801741130984
• UDI-Public: (01)00801741130984
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K170294
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/01/2019

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 Catalogue Number: 5991015
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/09/2019
• Initial Report FDA Received Date: 05/01/2019
• 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: Required Intervention
• Patient Age: 35 YR
• Patient Weight: 97