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

Catalog Number	5955810
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/30/2022
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, a ventralight st w/echo ps was used during a laparoscopic ventral hernia repair procedure on 30-sep-2022.It was reported that device was hydrated and rolled inside prior to insertion.A 12mm trocar was used and the mesh was successfully fixated in the correct position.As reported, after removing the echo ps from the patient¿s abdomen one of the four connectors was noted to be missing from the echo ps.The patient¿s abdominal cavity including the mesh were searched/inspected, however the missing connector could not be located.The surgeon completed the procedure assuming the connector was in between the abdomen and the mesh.There was no reported patient injury.
Additional Manufacturer Narrative
As reported, one of the four connectors was noted to have detached from the echo ps following removal from the patient¿s abdomen.The surgeon completed the procedure assuming the connector was left in vivo.A photo was provided of the echo ps balloon frame.Review of the photo confirms one of the mesh connectors is not present on the echo balloon frame.There is no damage identified to the echo frame or in the area of the fame where the connector would be present.Review of the photo cannot assist in determining a possible root cause.Based on the photo evaluation and investigation performed, root cause cannot be determined.Review of manufacturing records confirms product was manufactured to specification, with no indication of a manufacturing related cause for the event reported.(b)(4).Not returned.

• 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: 15640529
• Report Number: 1213643-2022-00662
• Device Sequence Number: 20253345
• Product Code: FTL
• UDI-Device Identifier: 00801741031786
• UDI-Public: (01)00801741031786
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K122436
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 10/06/2022

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: 02/28/2024
• Device Catalogue Number: 5955810
• Device Lot Number: HUGQ1299
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/30/2022
• Initial Report FDA Received Date: 10/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/05/2022
• 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