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	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Bowel Perforation (2668)
Date of Event	01/27/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, during laparoscopic ventral hernia repair procedure on (b)(6) 2022, when the bard/davol ventralight st w/echo 2 mesh was inserted with the introducer tool, the introducer tool hit and nicked bowel as surgeon was pushing the introducer tool through the trocar at the incision site.As reported, the surgeon removed the introducer tool and did not place the bard/davol ventralight st w/echo 2 mesh, instead bard/davol phasix st echo 2 was used after the bowel was repaired using silk suture.
Additional Manufacturer Narrative
As reported, during insertion of the ventralight st w/echo ps 2 with introducer tool, the patient¿s bowel was injured when the bowel was inadvertently ¿nicked¿ with the introducer tool.Requests for additional information have been made to the user facility, however no additional information has been provided.Based on the event as reported, this event has a use related root cause as the surgeon inadvertently ¿nicked¿ the patient¿s bowel during insertion of the device.Review of manufacturing records confirms product was manufactured to specification, with no indication of a manufacturing related cause for the event reported.To date, this is the only reported complaint from this manufacturing lot of 115 units released for distribution in november, 2021.
Additional Manufacturer Narrative
As reported, during insertion of the ventralight st w/echo ps 2 with introducer tool, the patient¿s bowel was injured when the bowel was inadvertently ¿nicked¿ with the introducer tool.Requests for additional information have been made to the user facility, however no additional information has been provided.Based on the event as reported, this event has a use related root cause as the surgeon inadvertently ¿nicked¿ the patient¿s bowel during insertion of the device.Review of manufacturing records confirms product was manufactured to specification, with no indication of a manufacturing related cause for the event reported.To date, this is the only reported complaint from this manufacturing lot of (b)(4) units released for distribution in november, 2021.
Event or Problem Description
As reported, during laparoscopic ventral hernia repair procedure on (b)(6) 2022, when the bard/davol ventralight st w/echo 2 mesh was inserted with the introducer tool, the introducer tool hit and nicked bowel as surgeon was pushing the introducer tool through the trocar at the incision site.As reported, the surgeon removed the introducer tool and did not place the bard/davol ventralight st w/echo 2 mesh, instead bard/davol phasix st echo 2 was used after the bowel was repaired using silk suture.

• 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: 13544622
• Report Number: 1213643-2022-00019
• Device Sequence Number: 19379864
• Product Code: FTL
• UDI-Device Identifier: 00801741130991
• UDI-Public: (01)00801741130991
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K170294
• 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
• Report Date (Section B): 01/31/2022

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: 08/28/2022
• Device Catalogue Number: 5990015
• Device Lot Number: HUFW0394
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/27/2022
• Initial Report FDA Received Date: 02/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/02/2021
• 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