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

Catalog Number	5990015
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/21/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As reported, a piece of the ventralight st w/ echo 2 positioning frame broke off when removed through an 8mm trocar.Note, the recommended trocar size per the ifu for product code 5990015 is 12mm.Photos provided show the frame with a section missing and a second photo shows the detached portion.The surgeon reports concern that fragments could be left in the patient, in review of the photos provided it appears all of the echo 2 ps was removed from the patient.As the sample was not returned for evaluation a definitive conclusion cannot be made, however it is possible that the issue presented due to the use of a trocar smaller than the recommended size.Per the instructions-for-use (ifu) provided with the device, instructs the user to "insert into the abdomen through the recommended minimum trocar or trocar incision site.Never force the device through the trocar.If the device 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.¿ and ¿note: the echo 2¿ positioning system frame is designed to separate into one strand when removed.It is recommended that the frame is removed from the same size trocar through which it was inserted.Review of the manufacturing records was performed and found that the lot 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.H3 other text : not returned.
Event or Problem Description
As reported, during a robotic ventral hernia repair procedure, a ventralight st w/ echo 2 positioning system was used.After fixating the mesh and removing the positioning frame through the 8mm trocar it was noted that a piece of the frame broke/tore off.The surgeon found the piece resting on top of the bowel and it was removed with no injury to the patient.As reported the surgeon had trouble locating the broken piece and had concern of fragments still in the abdomen.Reportedly it was unclear to the user if the positioning system was accidentally cut during removal.

• 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: 18314732
• Report Number: 1213643-2023-00487
• Device Sequence Number: 6690085
• Product Code: FTL
• UDI-Device Identifier: 00801741130991
• UDI-Public: (01)00801741130991
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K170294
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Other,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/29/2023

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: 5990015
• Device Lot Number: HUHV0895
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/21/2023
• Initial Report FDA Received Date: 12/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/06/2023
• 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