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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 Break (1069); Device Damaged by Another Device (2915)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/31/2018
Event Type  Malfunction  
Manufacturer Narrative

The sample evaluation confirms for broken inflation tube. Based on the reported information and sample evaluation it appears that the inflation tube break was the result of excessive tension / stretching of the inflation tube when the fixation device slipped and came into contact with the inflation tube. This complaint is confirmed for use related. 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 for this manufacturing lot of (b)(4) units released for distribution in (b)(4) 2018. 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.

 
Event Description

It was reported that on (b)(6) 2018 a ventralight st w/ echo ps was being used in a laparoscopic ventral hernia repair procedure. As reported, the echo ps balloon was fully inflated, and being held in position against the abdominal wall by hemostat. The surgeon was attempting to place the initial fasteners, using a non davol articulating fixation device. As reported the surgeon was having a hard time with the articulating tacker and was unable to get good purchase at the angle and the fixation device slipped from the position on the mesh, and the fixation device came into contact with the echo ps, this created tension and stretching of the inflation tube which cause the inflation tube to break. The inflation assembly and the mesh were completely removed from the patient's abdomen. Another of the same device was used to complete the case without further issue. There was no injury 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 sundberg
100 crossings blvd.
warwick, RI 02886
4018258462
MDR Report Key7629748
MDR Text Key112561826
Report Number1213643-2018-02139
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK130968
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 06/22/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/22/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date12/28/2019
Device Catalogue Number5955600
Device LOT NumberHUBZ0405
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer06/14/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/31/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured01/28/2018
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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