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U.S. Department of Health and Human Services

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

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DAVOL INC., SUB. C.R. BARD, INC. -1213643 VENTRALIGHT ST W/ ECHO 2 SURGICAL MESH Back to Search Results
Catalog Number 5990015
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/19/2021
Event Type  malfunction  
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 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.
 
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Brand NameVENTRALIGHT ST W/ ECHO 2
Type of DeviceSURGICAL 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 Key12287314
MDR Text Key265368499
Report Number1213643-2021-20236
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K170294
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 07/23/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/06/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/28/2021
Device Catalogue Number5990015
Device Lot NumberHUFN0601
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/29/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/19/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/30/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 08/06/2021 Patient Sequence Number: 1
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