• Decrease font size
  • Return font size to normal
  • Increase font size
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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

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 02/10/2016
Event Type  Injury  
Manufacturer Narrative
Based on the events as reported, the surgeon did not follow the instructions for removal as prescribed in the ifu. Step 10 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. As reported the event was user related and there was no device malfunction. 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: on (b)(6) 2016 during a ventral hernia repair while using a bard/davol ventralight st with echo ps the surgeon cut the inflation tube and removed the balloon assembly from the mesh, and placed it in the abdomen. He then had to tend to something else and forgot to remove the balloon assembly from the body. After closing the patient, but before leaving the o. R. The surgeon remembered he did not remove the inflation balloon so he reinserted his laparoscope and trocars and then removed the inflation balloon without any difficulty or injury to the patient.
 
Manufacturer Narrative
This is an addendum to the initial mdr to make a correction to the 510k number that was reported on the initial mdr.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key5467214
MDR Text Key39256820
Report Number1213643-2016-00076
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 user facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/10/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/29/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date10/31/2017
Device Catalogue Number5955450
Device Lot NumberHUZI1271
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location Hospital
Date Manufacturer Received03/01/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/20/2015
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: 02/29/2016 Patient Sequence Number: 1
-
-