MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. 3DMAX LIGHT; SURGICAL MESH

Catalog Number 0117320

Device Problems Difficult or Delayed Positioning (1157); Material Split, Cut or Torn (4008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/30/2020

Event Type  malfunction  

Manufacturer Narrative

It was reported that during a laparoscopic placement procedure using a 3dmax light mesh, it was noticed that the mesh was ¿cracked¿.However, the mesh was inserted through a trocar with an inner diameter of 12mm, it was reported that it was difficult to deploy the mesh down the trocar and therefore the mesh was removed.The device was returned for evaluation, with indication that the returned sample has been subject to an eto sterilization process.The initial evaluation noted one crack along the edge seal of the mesh, and the sample was noted to have visible blood staining with no visible indication that the device was handled with excessive force.While the ¿crack¿ was reported to be found prior to use, as reported the mesh had been handled, including at least partially being inserted and removed through a trocar.A review of the manufacturing records was performed for the subject lot and found that the lot was manufactured to specification.While the reported edge seal crack could occur during the manufacturing process, based on the available information, including the sample evaluation, a definitive cause of the edge seal crack cannot be determined.Pertaining to the surgeon reporting difficulty deploying the mesh through the trocar, the precautions section of the instructions for use states: "use an appropriate sized trocar to allow mesh to slide down the trocar with minimal force." to date, this is the only reported complaint from this manufacturing lot of (b)(4) units released for distribution in december 2019.If additional information becomes available, a supplemental emdr will be submitted.

Event Description

As reported, during laparoscopic placement procedure of 3dmax light mesh on (b)(6) 2020, it was noticed that the mesh was already cracked.However, the mesh was inserted through the trocar with the inner diameter of 12mm while it was difficult to deploy down the trocar and therefore the mesh was removed.The surgeon used unknown mesh to complete the procedure.There was no reported patient injury.

• Brand Name: 3DMAX LIGHT
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 100 crossings blvd.; warwick RI 02886
• Manufacturer (Section G): BARD SHANNON LIMITED 3005636544; san geronimo industrial park; lot #1, road #3, km 79.7; humacao PR 00791
• Manufacturer Contact: andrew topoulos ; 100 crossings blvd.; warwick, RI 02886 ; 4018258495
• MDR Report Key: 10307594
• MDR Text Key: 204017546
• Report Number: 1213643-2020-06851
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00801741031052
• UDI-Public: (01)00801741031052
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K091659
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,user faci
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0117320
• Device Lot Number: HUDY0934
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/01/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/14/2019
• 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