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

Catalog Number	5991015
Medical Device Problem Codes	Use of Device Problem (1670); Detachment of Device or Device Component (2907); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/13/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Per sample evaluation this complaint is confirmed for torn frame material resulting in the detachment of a portion (strut) of the frame.The sample evaluation found no manufacturing anomalies.Visual evaluation finds the echo 2 ps frame material was inadvertently torn to the point of detachment with forces applied while removing the frame through a 8 mm trocar.Per the instructions-for-use the recommended trocar size for product code 5991015 is 10 mm.This complaint is confirmed with a use related root cause as the surgeon used an 8 mm trocar during the procedure and not a 10 mm trocar as is recommended in the instructions-for-use.A review of the manufacturing records was performed and found that the lot was manufactured to specification.To date this is the only reported complaint for this production lot of 186 units released for distribution in march 2019.
Event or Problem Description
It was reported that on (b)(6) 2019 a first time user of the ventralight st w/ echo 2 ps was performing a laparoscopic cholecystectomy and ventral hernia repair.As reported 8 mm trocars were placed on both side of the abdomen.After successfully placing ventralight st mesh the surgeon pulled on the frame about a cm or 2 from the edge to pull out through the 8 mm trocar.As reported the surgeon was exerting additional force when removing the frame.It was noted that a strut detached from the frame and was left in the trocar.The strut was located and retrieved and there was no injury to the patient.

• Brand Name: VENTRALISHT ST W/ ECHO 2
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 100 crossings blvd.; warwick RI 02886
• MDR Report Key: 8654477
• Report Number: 1213643-2019-04460
• Device Sequence Number: 11220423
• Product Code: FTL
• UDI-Device Identifier: 00801741130984
• UDI-Public: (01)00801741130984
• 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: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/30/2019

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: 02/28/2020
• Device Catalogue Number: 5991015
• Device Lot Number: HUDN1066
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/13/2019
• Initial Report FDA Received Date: 05/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1