MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 3DMAX LIGHT; SURGICAL MESH

Catalog Number	0117322
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/31/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As reported,the 3dmax light mesh had a weak point and led to a hole when trying to insert it through the trocar.The subject device has been discarded by the user facility and not available for evaluation.Based on the information available and without having the sample to evaluate, no conclusions can be made.Review of manufacturing records confirms product was manufactured to specification.To date, this is the only reported complaint for this manufacturing lot (b)(4) released for distribution in oct, 2022.Regarding the deployment of the 3dmax, the instructions-for-use states, "use an appropriate sized trocar to allow mesh to slide down the trocar with minimal force".
Event or Problem Description
As reported, a 3dmax light mesh was being used during a laparoscopic procedure.It is reported that intraoperatively, it became apparent that there was a weak point in the mesh, and this led to a hole when trying to insert it through the trocar.It was reported that another 3dmax light mesh was used to complete the procedure.There was no reported patient injury.

• Brand Name: 3DMAX LIGHT
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC. -1213643; 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 ; 8005566756
• MDR Report Key: 16414305
• Report Number: 1213643-2023-00060
• Device Sequence Number: 5743167
• Product Code: FTL
• UDI-Device Identifier: 00801741031076
• UDI-Public: (01)00801741031076
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K091659
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 0117322
• Device Lot Number: HUGV1191
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/31/2023
• Initial Report FDA Received Date: 02/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/05/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown