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

Catalog Number	5990011
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/28/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As reported, following fixation the surgeon removed the echo 2 positioning system through a 5mm trocar.The instructions-for-use (ifu), supplied with the device recommends the use of a 10mm trocar for the product code (5990011) used.The sample was not returned for evaluation.Based on the information provided and without having the sample to evaluate, a definitive root cause cannot be determined.However, the most possible root cause is that the issue presented due to the use of the 5mm trocar which is smaller than the recommended size per the ifu.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 reported complaint for this manufacturing lot of (b)(4) units released for distribution in (b)(6) 2022.Not returned.
Event or Problem Description
As reported, during laparoscopic umbilical hernia repair procedure on (b)(6) 2022, the surgeon used the ventralight st w/echo 2 device.It was reported that during the procedure one 12mm port (for mesh insertion) and two 5mm ports (for scope and fixation device) were used.As reported, after inserting the mesh, the 12mm port was removed.Once the mesh was tacked into place, the surgeon grabbed the thinnest end of the echo 2 positioning system with a grasper, lining up the wire with the grasper and removed it through the 5mm port.As reported while removing the echo 2 positioning system through the 5mm port the white cover (frame) around the wire tore into two pieces and the entire wire come out of the frame.The surgeon verified that all pieces were accounted for.There was no patient injury as a result.

• 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: 15641830
• Report Number: 1213643-2022-00664
• Device Sequence Number: 6518932
• Product Code: FTL
• UDI-Device Identifier: 00801741130977
• UDI-Public: (01)00801741130977
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/04/2022

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: 05/28/2023
• Device Catalogue Number: 5990011
• Device Lot Number: HUGS2054
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/29/2022
• Initial Report FDA Received Date: 10/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/29/2022
• 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