MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 VENTRALIGHT ST W/ ECHO 2; SURGICAL MESH

Catalog Number	5991015
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/16/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As reported, a bard/davol ventralight st w/echo 2 (device 2) was used in a in a robotic umbilical hernia repair procedure.As reported during insertion through an intuitive surgical 12mm stapler cannula seal 470380 (device 1), there was a detachment of the echo 2 positioning system from the ventralight st implant.The ventralight st echo 2 sample was not returned for evaluation.Multiple requests for additional information have been made to the facility to gather additional details, however, no additional information was provided.The instructions-for-use (ifu) supplied with device 1 states: "insert into the abdomen through the recommended minimum trocar or trocar incision site.Never force the device through the trocar.If the device will not easily deploy down the trocar, remove the trocar and insert through the next largest available size trocar or through the trocar incision site and reinsert trocar." additionally, the ifu recommends the use of a 10mm trocar size for the product code used.At this time no definitive conclusions can be made as to why the detachment presented.Should additional information be provided, a supplemental mdr will be submitted.Not returned.
Event or Problem Description
The following was reported via fda 3500a form report ((b)(4)): "davol inc.Ventralight st mesh with echo 2 positioning system 10 cm x 15 cm (4" x 6") ellipse was being inserted through a port when plastic piece broke off.The ventralight st mesh has plastic frame that was too rigid/big to fit through port." the procedure being performed was a robotic umbilical hernia repair.As reported device 1 intuitive surgical 12mm stapler cannula seal 470380.No alleged patient injury was reported as a result of the problem experienced.

• Brand Name: VENTRALIGHT ST W/ ECHO 2
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC. -1213643; 100 crossings blvd.; warwick RI 02886
• MDR Report Key: 11663846
• Report Number: 1213643-2021-20073
• Device Sequence Number: 14227345
• Product Code: FTL
• UDI-Device Identifier: 00801741130984
• UDI-Public: (01)00801741130984
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K170294
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Report Source: other,user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 5991015
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 69 YR