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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. COMPOSIX L/P W/ ECHO SURGICAL MESH

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DAVOL INC., SUB. C.R. BARD, INC. COMPOSIX L/P W/ ECHO SURGICAL MESH Back to Search Results
Catalog Number 0144680
Device Problem Detachment of Device or Device Component (2907)
Patient Problems No Known Impact Or Consequence To Patient (2692); Device Embedded In Tissue or Plaque (3165)
Event Date 02/15/2020
Event Type  malfunction  
Manufacturer Narrative
The sample was not returned for evaluation. Based on the not having the sample returned, a definitive conclusion cannot be made. However, as reported an 11mm trocar was used and the surgeon did not maintain visualization of the product throughout the procedure. The instructions-for-use recommends the use of a 12mm trocar with product code 0114680 and states, "visualization should be maintained throughout the course of the entire procedure. " as such it is possible that the use of an 11mm trocar and not maintaining visualization of the device may have contributed to the issue reported. To date this is the only reported complaint for this production lot of (b)(4) units released for distribution in may, 2018. The dates of event and implant are estimated based on the information entered on the medwatch form as exact dates were not provided. The information provided by bd 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 bd. (b)(4).
 
Event Description
As reported per medwatch form (b)(4): "when using the mesh with the echo positioning system, the yellow plastic anchor fell off of the blue tubing inside of the patient (it fell off after the tubing was cut). The surgical team searched the abdomen extensively with the laparoscope and checked the trocars, including checking under the rubber gasket of the 11mm optiview trocar that was used with the mesh system. Radiology was called and a flat plate was taken of a second piece of the same mesh/positioning system. The piece was not radiopaque and did not have a marker, so the surgeon opted not to x-ray that patient's abdomen. The second piece was taken by the surgeon to show the patient's family. " this was a hernia repair surgery. The following was provided in follow up with the hospital contact: the case was a laparoscopic incisional repair. The inflation tube was grasped at the retrieval loop with a carter thomason grasper. The inflation assembly was used successfully to place the mesh. As reported, the yellow anchor was not visualized during the inflation process. As the surgeon was removing the inflation assembly "it got stuck in a port and as the surgeon attempted to remove it the small piece of plastic (yellow anchor) came apart and was lost. " no additional medical or surgical intervention was administered to the patient. The inflation assembly was not saved for return evaluation. The surgeon is reported to be an experienced user of the echo ps inflation device.
 
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Brand NameCOMPOSIX L/P 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 Key9948776
MDR Text Key193066842
Report Number1213643-2020-03378
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 other,user facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 04/27/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/10/2020
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/28/2020
Device Catalogue Number0144680
Device Lot NumberHUCP2458
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 Received04/16/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/30/2018
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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