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

Catalog Number	5955790
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/24/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As reported, during a surgical procedure, a portion of the green echo balloon of the ventralight st w/echo ps separated during removal through a 12 mm trocar.Returned for evaluation was the separated portion of the balloon confirming the reported event that the balloon tore while removing through the trocar.The instructions- for-use direct the user to pull the echo ps balloon up to the tip of the trocar and to remove the echo ps and the trocar simultaneously.As reported, the echo ps balloon was removed through the trocar without simultaneous removal of the trocar, at which time a portion of the balloon separated from the device.There were no issues noted with the balloon during deployment or use.The most probable root cause is inadvertent tearing of the balloon during removal through the trocar.A review of the manufacturing records was performed and found that the lot was manufactured to specification.To date, this is the only complaint for the reported lot of (b)(4) units released for distribution.The instructions-for-use, supplied with the device states, "to deflate and remove the echo ps¿ positioning system" states begin removal of the echo ps¿ positioning system by grasping one of the two removal points marked by the dark arrows adjacent to the bard ® logo.Begin pulling the positioning system off the mesh in one smooth motion.Continue removing the echo ps¿ positioning system by pulling it up to the tip of the trocar.Remove both the echo ps¿ positioning system and the trocar simultaneously." 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 laparoscopic ventral hernia repair procedure, a portion of the green echo balloon of the ventralight st w/echo ps separated during removal through a 12 mm trocar.The portion was removed from the patient.There was no patient injury.

• Brand Name: VENTRALIGHT ST W/ ECHO
• 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: 24839578
• Report Number: 1213643-2026-00469
• Device Sequence Number: 14959317
• Product Code: FTL
• UDI-Device Identifier: 00801741031762
• UDI-Public: (01)00801741031762(11)250221(17)270128(10)HUKP1418
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K122436
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 03/27/2026

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: 5955790
• Device Lot Number: HUKP1418
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/24/2026
• Initial Report FDA Received Date: 04/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/21/2025
• 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