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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 2 SURGICAL MESH

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DAVOL INC., SUB. C.R. BARD, INC. VENTRALIGHT ST W/ ECHO 2 SURGICAL MESH Back to Search Results
Catalog Number 5992025
Device Problems Use of Device Problem (1670); Torn Material (3024)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/27/2018
Event Type  malfunction  
Manufacturer Narrative
Based on the events as reported the user failed to remove the clamp from the hoisting suture and then cut the center hoisting suture close to the patient¿s skin as prescribed in the ifu. Resistance was felt by the surgeon due to him not removing the clamp and cutting the hoisting suture. Due to the resistance the surgeon pulled "swiftly" tearing the strut off of the frame. Root cause of the reported event is determined to be use-related. Regarding the removal of echo 2 positioning system frame, the instructions for use (ifu) states: "remove the atraumatic clamp or hemostat from the hoisting suture and, external to the patient cut the center hoisting suture close to the patient's skin. " 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
It was reported that on (b)(6) 2018 a bdi surgical / davol ventralight st w/ echo 2 device was being used in a robotic ventral hernia repair procedure. As reported the mesh was fixated and then the surgeon attempted to pull the frame from the mesh while the hoisting suture was still clamped at the skin level and due to this the surgeon met some resistance. When he pulled "swiftly" the arm (strut) tore from the device. The device was removed with no loose parts left behind. There was no patient injury. As reported there was a material separation, as such there was the possibility for an unintended fragment to fall into the body or be left in vivo. An mdr is filed to document this event.
 
Manufacturer Narrative
This is an addendum to the initial emdr to document the receipt of medwatch 3500a form. As initially reported to davol all parts were accounted for, following the procedure. Per the medwatch 3500a form and follow up with the contact the missing piece was not accounted for and the surgeon believes that it most likely fell on the floor. The surgeon did an extensive check of the body and did not locate the piece. Note that the information provided (catalog and lot #) of the medwatch 3500a form is incorrect. Davol followed up with the contact to verify, the contact confirmed that the initially reported catalog # (5992025) lot # (hubv0401) is correct as reported by davol. This additional information does not change the initial determination; root cause of the reported event is determined to be use-related. (b)(4).
 
Event Description
As reported on 03/20/2018: it was reported that on (b)(6) 2018 a bdi surgical / davol ventralight st w/ echo 2 device was being used in a robotic ventral hernia repair procedure. As reported the mesh was fixated and then the surgeon attempted to pull the frame from the mesh while the hoisting suture was still clamped at the skin level and due to this the surgeon met some resistance. When he pulled "swiftly" the arm (strut) tore from the device. The device was removed with no loose parts left behind. There was no patient injury. As reported there was a material separation, as such there was the possibility for an unintended fragment to fall into the body or be left in vivo. An mdr is filed to document this event.
 
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Brand NameVENTRALIGHT ST W/ ECHO 2
Type of DeviceSURGICAL MESH
Manufacturer (Section D)
DAVOL INC., SUB. C.R. BARD, INC.
100 crossings blvd.
warwick RI 02886
MDR Report Key7355683
MDR Text Key103013369
Report Number1213643-2018-00698
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
PMA/PMN Number
K170294
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 04/03/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/20/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/28/2018
Device Catalogue Number5992025
Device Lot NumberHUBV0401
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/27/2018
Is This a Reprocessed and Reused Single-Use Device? No

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