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

Catalog Number 5992025

Device Problems Use of Device Problem (1670); Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/27/2018

Event Type  malfunction  

Manufacturer Narrative

Based on the events as reported the user failed to remove the clamp from the hoisting suture and then cut the center hoisting suture close to the patient¿s skin as prescribed in the ifu.Resistance was felt by the surgeon due to him not removing the clamp and cutting the hoisting suture.Due to the resistance the surgeon pulled "swiftly" tearing the strut off of the frame.Root cause of the reported event is determined to be use-related.Regarding the removal of echo 2 positioning system frame, the instructions for use (ifu) states: "remove the atraumatic clamp or hemostat from the hoisting suture and, external to the patient cut the center hoisting suture close to the patient's skin." the information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.Not returned.

Event Description

It was reported that on (b)(6) 2018 a bdi surgical / davol ventralight st w/ echo 2 device was being used in a robotic ventral hernia repair procedure.As reported the mesh was fixated and then the surgeon attempted to pull the frame from the mesh while the hoisting suture was still clamped at the skin level and due to this the surgeon met some resistance.When he pulled "swiftly" the arm (strut) tore from the device.The device was removed with no loose parts left behind.There was no patient injury.As reported there was a material separation, as such there was the possibility for an unintended fragment to fall into the body or be left in vivo.An mdr is filed to document this event.

Manufacturer Narrative

This is an addendum to the initial emdr to document the receipt of medwatch 3500a form.As initially reported to davol all parts were accounted for, following the procedure.Per the medwatch 3500a form and follow up with the contact the missing piece was not accounted for and the surgeon believes that it most likely fell on the floor.The surgeon did an extensive check of the body and did not locate the piece.Note that the information provided (catalog and lot #) of the medwatch 3500a form is incorrect.Davol followed up with the contact to verify, the contact confirmed that the initially reported catalog # (5992025) lot # (hubv0401) is correct as reported by davol.This additional information does not change the initial determination; root cause of the reported event is determined to be use-related.(b)(4).

Event Description

As reported on 03/20/2018: it was reported that on (b)(6) 2018 a bdi surgical / davol ventralight st w/ echo 2 device was being used in a robotic ventral hernia repair procedure.As reported the mesh was fixated and then the surgeon attempted to pull the frame from the mesh while the hoisting suture was still clamped at the skin level and due to this the surgeon met some resistance.When he pulled "swiftly" the arm (strut) tore from the device.The device was removed with no loose parts left behind.There was no patient injury.As reported there was a material separation, as such there was the possibility for an unintended fragment to fall into the body or be left in vivo.An mdr is filed to document this event.

• Brand Name: VENTRALIGHT ST W/ ECHO 2
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 100 crossings blvd.; warwick RI 02886
• MDR Report Key: 7355683
• MDR Text Key: 103013369
• Report Number: 1213643-2018-00698
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00801741131042
• UDI-Public: (01)00801741131042
• Combination Product (y/n): N
• PMA/PMN Number: K170294
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 04/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/28/2018
• Device Catalogue Number: 5992025
• Device Lot Number: HUBV0401
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1