MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 VENTRALIGHT ST W/ ECHO 2; SURGICAL MESH

Catalog Number 5991015

Device Problem Material Separation (1562)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/03/2023

Event Type  malfunction  

Event Description

As reported, during a procedure when the surgeon inserted the ventralight st w/echo 2 ps into the patient's abdomen through a trocar (size is unknown), the positioning system came apart from the mesh.It was reported that the mesh and positioning system was removed from the patient body.The surgeon used another ventralight st w/echo 2 to complete the procedure.There was no reported patient injury.

Manufacturer Narrative

Based on the information available, no conclusions can be made.The subject device has been discarded as such is not available for evaluation.As reported, the echo 2 positioning system came apart from the ventralight st mesh when inserting down the trocar.The trocar size used during the procedure was unknown by the complainant.The instructions-for-use (ifu) recommends the use of a 10mm trocar size for the product code used.Per the ifu: "hold the tightly rolled frame and grasp the leading edge of the device with an atraumatic grasper or grasping tool.Take care to grasp both mesh and frame material at approximately a 45-degree angle.A black line indicates the suggested location to grasp the mesh.With the grasper, insert the leading edge of the rolled device into the trocar or incision site.Do not let the rolled mesh bend as it is inserted into the trocar.In one continuous movement, deploy the device into the abdomen.Maintain visualization of the device via laparoscope, as it is deployed into the abdomen." review of manufacturing records confirms product was manufactured to specification.To date, this is the only reported complaint for this manufacturing lot of (b)(4) units released for distribution in september 2022.

• Brand Name: VENTRALIGHT ST W/ ECHO 2
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC. -1213643; 100 crossings blvd.; warwick RI 02886
• Manufacturer (Section G): DAVOL INC., SUB. C.R. BARD, INC. -1213643; 100 crossings blvd.; warwick RI 02886
• Manufacturer Contact: andrew topoulos ; 100 crossings blvd.; warwick, RI 02886 ; 8005566756
• MDR Report Key: 16420153
• MDR Text Key: 310093420
• Report Number: 1213643-2023-00063
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00801741130984
• UDI-Public: (01)00801741130984
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K170294
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/28/2023
• Device Catalogue Number: 5991015
• Device Lot Number: HUGV0344
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/14/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other