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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 SURGICAL MESH

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DAVOL INC., SUB. C.R. BARD, INC. -1213643 VENTRALIGHT ST W/ ECHO SURGICAL MESH Back to Search Results
Catalog Number 5955790
Device Problems Material Separation (1562); Failure to Unfold or Unwrap (1669)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/06/2021
Event Type  malfunction  
Event Description
As reported, during a robotic-assisted laparoscopic ventral hernia repair procedure on (b)(6) 2021, when the bard/davol ventralight st mesh w/echo ps was inserted through the trocar, the mesh edge was stuck to itself and would not fully open. As reported, the mesh was removed and another mesh was used to complete the case. As reported, the surgeon is an experienced user and there was no patient harm or injury.
 
Manufacturer Narrative
The subject device was returned and has been evaluated. Visual evaluation confirms a section of the hydrogel coating is stuck together transferring the hydrogel material. A void was noted in the material, however hydrogel was still present where the hydrogel material stuck together. No manufacturing anomalies were found. It is unknown if the mesh was hydrated prior to use. Implantation of a non-hydrated mesh may result in the hydrogel becoming hydrated from body fluids resulting in a hydrated and a dry section of the barrier sticking together. This can result in the separation of the barrier. The instructions-for-use, supplied with the device, state the mesh should be hydrated for no more than 1-3 seconds prior to use and rolled immediately to protect the bioresorbable coating, and recommends the use of a 12mm trocar size for the product code used. Based on the sample evaluation and investigation performed, the most probable root cause is an event occurring during user /device interface during deployment. A review of the manufacturing records was performed and found that the lot was manufactured to specification. To date, this is the only reported complaint from this manufacturing lot of (b)(4) units released for distribution in jan, 2021.
 
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Brand NameVENTRALIGHT ST W/ ECHO
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 Key12786217
MDR Text Key280579804
Report Number1213643-2021-20401
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K122436
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,User Facility
Reporter Occupation
Type of Report Initial
Report Date 10/26/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/10/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number5955790
Device Lot NumberHUEY0842
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/27/2021
Date Manufacturer Received10/21/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/20/2021
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: 11/10/2021 Patient Sequence Number: 1
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