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

Catalog Number	5990015
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	06/02/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As reported, one of the blue connectors detached from the echo ps 2 while being removed from the trocar.The connector was located and there was no patient injury reported.It is reported that the subject device is being returned for evaluation; however at this time has not been received.Based on the information available, no conclusions can be made.Note, the dates of event and implant are estimated based on the information provided.The instructions-for-use, suppled with the device states, "begin removal of the echo 2¿ positioning system frame by grasping one of the designated points indicated by the ¿remove¿ symbol or anywhere along the green removal indicator line on the frame.Removing from any other location is not recommended.Begin pulling the positioning system off the mesh in one smooth motion.The connectors that attach the frame to the mesh will detach one-by-one from the mesh.Maintain constant visualization and ensure no tissue or organs are caught while removing the frame through the trocar.Never remove the device from the center frame struts.".
Event or Problem Description
As reported, during a procedure, a bard/davol ventralight st w/echo ps 2 was used.It is reported that one of the blue tabs (connectors) was cut and flew out of the sterile field after pulling the echo ps 2 out of the trocar.The missing blue tab (connector) was found.As reported, there was no reported patient injury.
Event or Problem Description
As reported, during a procedure, a bard/davol ventralight st w/echo ps 2 was used.It is reported that one of the blue tabs (connectors) was cut and flew out of the sterile field after pulling the echo ps 2 out of the trocar.The missing blue tab (connector) was found.As reported, there was no reported patient injury.
Additional Manufacturer Narrative
As reported, one of the blue connectors detached from the echo ps 2 while being removed from the trocar.The connector was located and there was no patient injury reported.It is reported that the subject device is being returned for evaluation; however at this time has not been received.Based on the information available, no conclusions can be made.Note, the dates of event and implant are estimated based on the information provided.The instructions-for-use, supplied with the device states, "begin removal of the echo 2¿ positioning system frame by grasping one of the designated points indicated by the ¿remove¿ symbol or anywhere along the green removal indicator line on the frame.Removing from any other location is not recommended.Begin pulling the positioning system off the mesh in one smooth motion.The connectors that attach the frame to the mesh will detach one-by-one from the mesh.Maintain constant visualization and ensure no tissue or organs are caught while removing the frame through the trocar.Never remove the device from the center frame struts." addendum: this is an addendum to the initial mdr submitted.This supplemental mdr is submitted to report the evaluation results of the sample.Based on the event reported and sample evaluation, the blue connector was inadvertently pulled out of the frame from applied force in use.No manufacturing anomalies were found.The instructions-for-use supplied with the device recommends minimum trocar size of 12mm.Size used in the case was not able to be obtained.Review of manufacturing records confirms product was manufactured to specification, with no indication of a manufacturing related cause for the event reported.To date, this is the only complaint reported for this manufacturing lot of (b)(4) units released for distribution in february, 2022.Note: section a through f - 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.H3 other text : sample evaluated.

• 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
• Manufacturer (Section G): BARD SHANNON LIMITED -3005636544; san geronimo industrial park; lot #1, road #3, km 79.7; humacao PR 00791
• Manufacturer Contact: andrew topoulos ; 100 crossings blvd.; warwick, RI 02886 ; 8005566756
• MDR Report Key: 14776768
• Report Number: 1213643-2022-00456
• Device Sequence Number: 5779891
• Product Code: FTL
• UDI-Device Identifier: 00801741130991
• UDI-Public: (01)00801741130991
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K170294
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Other,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/05/2022

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 Expiration Date: 11/28/2022
• Device Catalogue Number: 5990015
• Device Lot Number: HUFZ1395
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/02/2022
• Supplement Date Received by Manufacturer: 06/30/2022
• Initial Report FDA Received Date: 06/22/2022
• Supplement Report FDA Received Date: 07/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/18/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown