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

Catalog Number	5955680
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/17/2023
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, during a laparoscopic procedure the ventralight st w/echo ps mesh was inserted through the 8mm robotic trocar, the mesh got stuck and resulted in a piece of the mesh/positioning system breaking when removed.It was reported that the mesh did not enter the abdomen and all pieces were removed.As reported, another of the same device was used to complete the procedure using upsized trocar.There was no reported patient injury.
Additional Manufacturer Narrative
As reported, an 8mm trocar was used to deploy the 6¿x 8¿ ventralight st w/echo ps resulting in the separation of a piece of the device within the trocar.The instructions-for-use (ifu), supplied with the device recommends the use of a minimum 12mm trocar for the product code (5955680) used.The trocar size was increased and another 6¿x 8¿ ventralight st w/echo ps was successfully deployed and implanted.Based on the information provided, this event is identified as a use related issue due to the incorrect (too small) trocar size used.Review of manufacturing records confirms product was manufactured to specification.(b)(4).Per the ifu "the ventralight st mesh with echo ps positioning system must be rolled immediately after hydration.Using the introducer tool or grasper roll the ventralight st mesh with echo ps positioning system parallel to the bard logo with the polypropylene on the outside and bioresorbable coated side with the echo ps positioning system on the inside.Insert into the abdomen through the recommended minimum trocar or trocar incision site.Do not force the device through the trocar.If the ventralight¿ st mesh with echo ps positioning system will not easily deploy down the trocar, remove the trocar and insert through the next largest available size trocar or through the trocar incision site and reinsert trocar".
Event or Problem Description
As reported, during a laparoscopic procedure the ventralight st w/echo ps mesh was inserted through the 8mm robotic trocar, the mesh got stuck and resulted in a piece of the mesh/positioning system breaking when removed.It was reported that the mesh did not enter the abdomen and all pieces were removed.As reported, another of the same device was used to complete the procedure using upsized trocar.There was no reported patient injury.
Additional Manufacturer Narrative
As reported, an 8mm trocar was used to deploy the 6¿x 8¿ ventralight st w/echo ps resulting in the separation of a piece of the device within the trocar.The instructions-for-use (ifu), supplied with the device recommends the use of a minimum 12mm trocar for the product code (5955680) used.The trocar size was increased and another 6¿x 8¿ ventralight st w/echo ps was successfully deployed and implanted.Based on the information provided, this event is identified as a use related issue due to the incorrect (too small) trocar size used.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 2022.Per the ifu "the ventralight st mesh with echo ps positioning system must be rolled immediately after hydration.Using the introducer tool or grasper roll the ventralight st mesh with echo ps positioning system parallel to the bard logo with the polypropylene on the outside and bioresorbable coated side with the echo ps positioning system on the inside.Insert into the abdomen through the recommended minimum trocar or trocar incision site.Do not force the device through the trocar.If the ventralight¿ st mesh with echo ps positioning system will not easily deploy down the trocar, remove the trocar and insert through the next largest available size trocar or through the trocar incision site and reinsert trocar".Addendum: this is an addendum to the initial mdr submitted.This supplemental mdr is submitted to correct the patient id which was inadvertently entered in the initial mdr.Updated fields: b4, g3, g6, h2, h6, h10.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 : not returned - sample discarded.

• 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: 16538667
• Report Number: 1213643-2023-00086
• Device Sequence Number: 6325575
• Product Code: FTL
• UDI-Device Identifier: 00801741031755
• UDI-Public: (01)00801741031755
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K122436
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/23/2023

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 Expiration Date: 07/28/2024
• Device Catalogue Number: 5955680
• Device Lot Number: HUGV0250
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/20/2023
• Supplement Date Received by Manufacturer: 03/21/2023
• Initial Report FDA Received Date: 03/14/2023
• Supplement Report FDA Received Date: 03/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/25/2022
• 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