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

Catalog Number	5991520
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Codes	Injury (2348); Foreign Body In Patient (2687)
Date of Event	10/09/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the events as reported, the echo ps positioning system was not removed from the patient as prescribed in the instructions-for-use.This complaint 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.Discarded.
Event or Problem Description
It was reported that on (b)(6) 2018 during a laparoscopic ventral hernia repair using the ventralight stw/ echo 2 ps, the surgeon inadvertently left the echo 2 ps positioning system in vivo at the close of the case.As reported the surgeon "woke up at 2am realizing he had left the device in the patient." the next day, the surgeon brought the patient back to surgery to remove the device.The entire echo 2 ps was removed without further complications.As reported the patient stayed in the hospital for 6 days and was then discharged home.This was the surgeon's first case using the echo 2 ps device, however is an established user of the echo (1) device.

• 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: 8026245
• Report Number: 1213643-2018-03821
• Device Sequence Number: 1380558
• Product Code: FTL
• UDI-Device Identifier: 00801741131004
• UDI-Public: (01)00801741131004
• Combination Product (Y/N): N
• Initial Reporter State: SD
• Initial Reporter Country: US
• PMA/510(K) Number: K170294
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/31/2018

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: 04/28/2019
• Device Catalogue Number: 5991520
• Device Lot Number: HUCR0304
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/10/2018
• Initial Report FDA Received Date: 10/31/2018
• 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: Hospitalization; Required Intervention
• Patient Age: 73 YR
• Patient Weight: 90