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

Catalog Number	5955600
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As reported, during a robotic hernia repair the yellow anchor of the ventralight st echo ps, got stuck in the patient's fascia when pulling the inflation tube through abdominal wall.Often during robotic repairs, the primary defect is closed prior to placing the mesh, this can inhibit the passage of the inflation tube while pulling through the anatomy.Note it is unknown if the primary defect was closed in this case.Evaluation of the returned echo ps assembly found visible material deformation at the weld site on the inflation tube.The deformation found is from the rf weld performed on the anchor and serves as evidence that the anchor / weld process was properly performed.Based on the sample evaluation and investigation performed, the most probable root cause is that resistance was encountered when pulling the inflation assembly through the patient¿s anatomy causing the detachment at the anchor.To date, this is the only reported complaint for this manufacturing lot of 116 units released for distribution in june 2022.A review of manufacturing records was performed and confirms product was made to specification.The instructions-for-use (ifu) supplied with the device states: "once the ventralight st mesh w/echo ps positioning system (the device) is inserted into the abdomen, use a grasper to locate the blue retrieval loop on the inflation tube, ensuring that the blue inflation tube is not wrapped around the mesh and is clearly visible.Pass a suture passer device through healthy skin at the center of the hernia defect (avoid going directly through the umbilicus).Grasp the blue retrieval loop and pull the retrieval loop and inflation tube out of the abdominal cavity.Sample evaluated.
Event or Problem Description
As reported, during a robotic umbilical hernia repair on (b)(6) 2022, a ventralight st mesh w/echo ps was implanted through 12mm trocar to the patient.It is reported that after insertion, when the surgeon was pulling the inflation tube up through the abdominal wall skin incision, the inflation tube broke, and the yellow anchor got stuck in the patient's fascia.As reported, the surgeon was able to inflate the echo ps and fixate the mesh without any issues; however, after they removed the echo ps once the mesh was fixated, they noticed the yellow anchor was missing so the surgeon made an extension of the skin incision to retrieve the yellow anchor and piece of inflation tube.No patient harm or injury was reported.

• 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: 15829687
• Report Number: 1213643-2022-00754
• Device Sequence Number: 5072137
• Product Code: FTL
• UDI-Device Identifier: 00801741031731
• UDI-Public: (01)00801741031731
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K130968
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Other,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/28/2024
• Device Catalogue Number: 5955600
• Device Lot Number: HUGS0536
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/01/2022
• Initial Report FDA Received Date: 11/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/23/2022
• 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: Required Intervention
• Patient Sex: Unknown