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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 UNKAA087
Device Problem Use of Device Problem (1670)
Patient Problem Injury (2348)
Event Date 04/15/2016
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, the surgeon did not remove the echo ps positioning system from the patient as prescribed in the ifu; this complaint is confirmed as 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 the surgeon, inadvertently left the balloon assembly of a ventralight st w/ echo positioning system in the patient. This was noted 3-min after closing the patient. Doctor scrubbed back in and surgical intervention was performed to remove the balloon assembly. Contact reports that the surgeon uses a 5mm trocar. He had placed several fasteners and due to the patient size needed to insert additional trocars to facilitate fixation. At this time he had deflated the balloon assembly and removed the balloon off the mesh, but had not remove it from the abdominal space. He placed the trocars, completed fixation and closed the patient. The surgeon is reported to be an experienced user of the echo positioning system. As reported the event resulted in the need for surgical intervention, beyond that there was no patient injury as a result of this event.
 
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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 Key5690823
MDR Text Key46264760
Report Number1213643-2016-00237
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K122436
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial
Report Date 05/09/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/01/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNKAA087
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location Hospital
Date Manufacturer Received05/09/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 06/01/2016 Patient Sequence Number: 1
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