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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 5955610
Device Problems Use of Device Problem (1670); Detachment of Device or Device Component (2907)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/17/2018
Event Type  malfunction  
Manufacturer Narrative
As reported one of the connectors detached from the echo ps while the user was removing it through the trocar. Photos of the echo ps were provided along with an intraoperative photo showing the connector loose in the patient's abdomen. The photo evaluation confirms detachment of one of the connectors from the echo ps. Regarding removal of the echo ps the instructions-for-use prescribes that the user remove the echo ps and trocar simultaneously. Based on the information provided and photo evaluation the echo ps connector appears to have detached from forces applied while removing the echo ps through, and not simultaneously with, the trocar as prescribed in the instructions-for-use. Regarding the removal of the balloon the instructions-for-use states, "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 the mesh in one smooth motion. Continue removing the echo ps¿ positioning system, pulling it up to the tip of the trocar. Remove both the echo ps¿ positioning system and trocar simultaneously. Verify that the echo ps¿ positioning system including the balloon, all mesh connectors, and the inflation tube is fully intact, discard the echo ps¿ positioning system appropriately. " a review of the manufacturing records was performed and found that the lot was manufactured to specification. 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. Due to privacy laws in (b)(6), the customer has not provided any patient details. Not returned.
 
Event Description
It was reported that on (b)(6) 2018 a ventralight st w/ echo ps was used during a laparoscopic repair procedure. As reported while removing the echo ps through the trocar one of the connectors detached from the echo ps. It was located and retrieved from the patients abdomen. There was 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 sundberg
100 crossings blvd.
warwick, RI 02886
4018258462
MDR Report Key7588943
MDR Text Key111159791
Report Number1213643-2018-01886
Device Sequence Number1
Product Code FTL
UDI-Device Identifier00801741031748
UDI-Public(01)00801741031748
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K122436
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 06/11/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/11/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/28/2018
Device Catalogue Number5955610
Device Lot NumberHUAX1302
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/17/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/30/2016
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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