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

Catalog Number	0117320
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/28/2022
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, during a tapp procedure on (b)(6) 2022, using a 3dmax light mesh, the surgeon rolled the mesh prior to insertion, and it was noted that the edge of the mesh was torn.It was reported that the mesh was removed from the patient's body and another mesh was used to complete the procedure.There was no reported patient injury.
Additional Manufacturer Narrative
As reported, the sample is being returned for evaluation, but at this has not been received.Based on the information available and without having the sample to evaluate, no conclusions can be made at this time.If/when the sample is received and the evaluation has been completed, a supplemental mdr will be submitted to document the results.Review of manufacturing records confirms product was manufactured to specification.
Event or Problem Description
As reported, during a tapp procedure on (b)(6) 2022, using a 3dmax light mesh, the surgeon rolled the mesh prior to insertion, and it was noted that the edge of the mesh was torn.It was reported that the mesh was removed from the patient's body and another mesh was used to complete the procedure.There was no reported patient injury.
Additional Manufacturer Narrative
As reported, the sample is being returned for evaluation, but at this has not been received.Based on the information available and without having the sample to evaluate, no conclusions can be made at this time.If/when the sample is received and the evaluation has been completed, a supplemental mdr will be submitted to document the results.Review of manufacturing records confirms product was manufactured to specification.Addendum: this is an addendum to the initial mdr submitted.This supplemental mdr is submitted to report the results of the sample evaluation.Visual evaluation of the sample finds there are multiple tears in the edge seal from handling.It also appears that a surgical tool / graspers were used during the placement attempt.Based on the sample evaluation and investigation performed, root cause is determined to be user/device interface while handling the mesh with graspers while attempting to deploy.No manufacturing anomalies were found.Per the instructions-for-use (ifu) supplied with the device, "use an appropriate sized trocar to allow mesh to slide down the trocar with minimal force".Note: section a through f - the information provided by bd 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 bd.H3 other text : sample evaluated.

• 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: 16004550
• Report Number: 1213643-2022-00804
• Device Sequence Number: 20517919
• Product Code: FTL
• UDI-Device Identifier: 00801741031052
• UDI-Public: (01)00801741031052
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K091659
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/27/2022

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: 0117320
• Device Lot Number: HUGR1565
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/30/2022
• Supplement Date Received by Manufacturer: 12/28/2022
• Initial Report FDA Received Date: 12/19/2022
• Supplement Report FDA Received Date: 12/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/16/2022
• 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