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	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/19/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device was returned for evaluation.The sample evaluation confirms for torn frame material resulting in the detachment of a portion of the frame.No manufacturing anomalies were found.As reported, the issue presented when the user attempted to remove the echo 2 ps through an 8mm trocar.The instructions-for-use (ifu) recommends the use of a 12mm trocar size for the product code used.Evaluation of the sample found that the echo ps 2 frame material was inadvertently torn most likely due to forces applied while removing the frame through a 8mm trocar.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 complaint reported for this manufacturing lot of (b)(4) units released for distribution in march, 2021.
Event or Problem Description
As reported, during a laparoscopic ventral hernia repair with a 2 cm defect on (b)(6) 2021, the surgeon used a bard/davol ventralight st mesh w/echo 2 positioning system.As reported, a 10mm camera port and x2 8mm ports were used for the mesh insertion/removal.Following placement and fixation of the ventralight st mesh, the surgeon attempted to remove the echo 2 ps frame through the 8 mm port, and one of the "spokes" detached from the frame.The detached portion (spoke) of the frame was completely removed along with the rest of the frame and there was no delay in the case.The surgeon is an experienced user of the device.There was no reported patient injury.

• 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
• MDR Report Key: 12287314
• Report Number: 1213643-2021-20236
• Device Sequence Number: 3807151
• Product Code: FTL
• UDI-Device Identifier: 00801741130991
• UDI-Public: (01)00801741130991
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K170294
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/23/2021

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: 12/28/2021
• Device Catalogue Number: 5990015
• Device Lot Number: HUFN0601
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/19/2021
• Initial Report FDA Received Date: 08/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 41 YR