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U.S. Department of Health and Human Services

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

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DAVOL INC., SUB. C.R. BARD, INC. VENTRALIGHT ST W/ECHO SURGICAL MESH Back to Search Results
Catalog Number 5955600
Device Problems Detachment of Device or Device Component (2907); Torn Material (3024)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/24/2016
Event Type  malfunction  
Manufacturer Narrative
The sample was not returned to davol for evaluation, therefore no definitive conclusions can be made at this time. As reported the balloon was pulled through the trocar during removal. The instructions for use, which are supplied with the device, prescribe that the balloon be removed simultaneously with the trocar, not pulled through the trocar, stating, "begin removal of the echo ps¿ positioning system by grasping one of the two removal points marked by the dark arrows adjacent to the bard® logo. Begin pulling the positioning system off of the mesh in one smooth motion. Continue removing echo ps¿ positioning system and trocar simultaneously. " a review of the manufacturing records was performed and found that the lot was manufactured to specification. The 3500a form reported that the device was available for return; multiple attempts have been made to secure the return of the sample for evaluation, however to date the sample has not been returned to davol.
 
Event Description
The following was reported to davol by the fda via medwatch 3500a report: (b)(4). Surgeon tacked mesh to abdominal wall with absorbable tacks, removing echo ps positioning system from tacked mesh by pulling in normal fashion. The echo ps positioning system was delivered through a 12mm operative port with laparoscopic grasper. While doing, surgeon discovered that a piece (approx. 4. 5cm x 2cm) tore from the main body of the echo positioning framework landing on the mesentery. Retrieval was done by surgeon immediately, with laparoscopic instrument. The torn piece was compared to the missing area on the main body of the positioning system (previously delivered) and determined by the surgeon that the entire torn piece was removed successfully causing no harm to the patient.
 
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Brand NameVENTRALIGHT ST W/ECHO
Type of DeviceSURGICAL MESH
Manufacturer (Section D)
DAVOL INC., SUB. C.R. BARD, INC.
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
laura berg
100 crossings blvd.
warwick, RI 02886
4018258462
MDR Report Key6083552
MDR Text Key59361490
Report Number1213643-2016-00509
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K130968
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 10/14/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/07/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/28/2017
Device Catalogue Number5955600
Device Lot NumberHUZK0663
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location Hospital
Date Manufacturer Received10/14/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/27/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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