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

Catalog Number	5991520
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/11/2024
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, during a robotic ventral hernia repair procedure, the ventralight st echo 2 ps was removed from the packaging, and on the sterile field it was noted that a piece of one of the purple connectors (the tail of it) was broken off.It was reported that the mesh remained intact with all connectors and the surgeon was able to use the mesh without any issue.As reported, the piece that broke off was discarded.There was no patient harm or injury.
Additional Manufacturer Narrative
As reported, a piece of one of the connectors on the ventralight st echo 2 ps was noted to have broken off.The mesh was implanted without issue.The connector was discarded by the user facility.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 of (b)(4) units released for distribution in october 2023.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.
Additional Manufacturer Narrative
As reported, a piece of one of the connectors on the ventralight st echo 2 ps was noted to have broken off.The mesh was implanted without issue.The connector was discarded by the user facility.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 of (b)(4) units released for distribution in october 2023.Addendum: h11: this supplemental mdr is submitted to document the completed sample evaluation results.Evaluation of the returned sample finds that all seven (7) connectors remain attached to the frame.There was no damage found to the seven connectors.In the as received condition the frame material is torn resulting in the detachment of a portion of the frame.The frame material tear is jagged indicating the material torn from forces applied.It is not a clean cut.Based on the sample evaluation performed, it was found that the echo 2 ps frame material was inadvertently torn most likely due to forces applied while removing the frame.No manufacturing anomalies found.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.
Event or Problem Description
As reported, during a robotic ventral hernia repair procedure, the ventralight st echo 2 ps was removed from the packaging, and on the sterile field it was noted that a piece of one of the purple connectors (the tail of it) was broken off.It was reported that the mesh remained intact with all connectors and the surgeon was able to use the mesh without any issue.As reported, the piece that broke off was discarded.There was no patient harm or injury.

• Brand Name: VENTRALIGHT ST W/ ECHO 2
• 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: 19583920
• Report Number: 1213643-2024-00328
• Device Sequence Number: 7279881
• Product Code: FTL
• UDI-Device Identifier: 00801741131004
• UDI-Public: (01)00801741131004(17)240828(10)HUHW0758
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K170294
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/16/2024

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 Expiration Date: 08/28/2024
• Device Catalogue Number: 5991520
• Device Lot Number: HUHW0758
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/12/2024
• Supplement Date Received by Manufacturer: 07/15/2024
• Initial Report FDA Received Date: 06/21/2024
• Supplement Report FDA Received Date: 07/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/30/2023
• 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