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	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/06/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
As per mdr report: "surgeon did not remove the positioning piece of the mesh when sutured into place during a ventral hernia repair.Patient had to return to the or for removal.Fda safety report id # (b)(4).".
Additional Manufacturer Narrative
As reported, the ventralight st w/ echo 2 positioning frame was inadvertently left in the patient following mesh implant; the patient underwent subsequent surgical intervention for the removal for echo 2 ps.Based on the information provided the reported event is determined to be use related with no malfunction of the device as the instructions-for-use were not followed.The instructions-for-use (ifu) supplied with the device adequately describe the proper technique for removal of echo 2¿ positioning system frame.The precautions section states ¿visualization must be maintained throughout the course of the entire surgical procedure.Additionally, laparoscopic removal of the echo 2¿ positioning system frame must be performed under sufficient visualization of the entire device and surrounding anatomy, to ensure proper removal.¿ the waring section of the ifu states, ¿discard the echo 2¿ positioning system (including the frame, center hoisting suture, all connectors and mesh introducer) after use.¿ 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.Device not returned - remains implanted.

• 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: 15690032
• Report Number: 1213643-2022-00679
• Device Sequence Number: 15299873
• Product Code: FTL
• UDI-Device Identifier: 00801741130984
• UDI-Public: (01)00801741130984
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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,Health Professional,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2023
• Device Catalogue Number: 5991015
• Device Lot Number: HUGQ1698
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/07/2022
• Initial Report FDA Received Date: 10/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Required Intervention
• Patient Age: 28 YR
• Patient Sex: Unknown
• Patient Weight: 104 KG