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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 5955450
Device Problem Use of Device Problem (1670)
Patient Problem Injury (2348)
Event Date 01/08/2016
Event Type  Injury  
Manufacturer Narrative
The ifu for the ventralight st w/ echo was reviewed. Step 10 in directions for using the ventralight st w/ echo positioning system states "begin removal of the echo ps positioning system by pulling it up to the tip of the trocar. Remove both the echo ps positioning system and trocar simultaneously. The ifu also notes the user should verify that the echo ps positioning system including the balloon, all mesh connectors, and the inflation tube is fully intact after removal. Based on the events as reported, following the procedure the or staff did not verify removal of the echo ps positioning system, this complaint is confirmed as being use related with no malfunction of the device. The information provided by bard represents all of the known information at this time. Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard. Not returned.
 
Event Description
The following was reported to davol: it is reported that on (b)(6) 2016 the surgeon performed a laparoscopic ventral hernia repair with a bard ventralight st w/ echo. Two days later on (b)(6) 2016 the surgeon was thinking about the case and could not remember if she removed the echo balloon assembly from the mesh. On (b)(6) 2016 the surgeon took the patient back to the or and performed a laparoscopy, which confirmed that the balloon was not left in the patient. The surgeon indicated the patient is doing well at this time.
 
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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 Key5379485
MDR Text Key36401685
Report Number1213643-2016-00016
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
PMA/PMN Number
K130968
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial
Report Date 01/07/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/20/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date11/30/2017
Device Catalogue Number5955450
Device Lot NumberHUZJ0335
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location Hospital
Date Manufacturer Received01/07/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/16/2015
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: 01/20/2016 Patient Sequence Number: 1
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