MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. VENTRALIGHT ST W/ECHO

Catalog Number UNKAA087

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  Injury  

Event Description

The following was reported to davol by the sales rep: it was reported that the surgeon was using an echo ps inflation device during a laparoscopic ventral hernia repair.Reportedly, the procedure was completed and the patient was sent to the pacu; however, the surgeon then realized he had not removed the balloon portion of the echo positioning system and had left it in the patient.The patient was immediately returned to the operating room and put under anesthesia, reopened and the balloon inflation assembly was completely removed.There were no add'l patient injuries and the device is confirmed to have been completely removed from the mesh.The surgeon is reported to be an experienced user of the echo positioning system and the occurrence was purely an error on his part, with no malfunction of the device.

Manufacturer Narrative

Based on the events as reported, the surgeon did not follow the instructions for removal as prescribed in the ifu.The surgeon is reported to be an experienced user of the product who has performed the process multiple times with no issue of this nature occurring.As reported the event was user related and there was no device malfunction.

• Brand Name: VENTRALIGHT ST W/ECHO
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; warwick RI
• Manufacturer (Section G): BARD SHANNON LIMITED; san geronimo industrial park; lot #1, road #3, km 79.7; humacao PR 00791
• Manufacturer Contact: laura berg ; 100 crossings boulevard; warwick, RI 02886 ; 8005566756
• MDR Report Key: 3940716
• MDR Text Key: 4531109
• Report Number: 1213643-2014-00197
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110820
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/04/2014

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
• Device Operator: Health Professional
• Device Catalogue Number: UNKAA087
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/04/2014
• Initial Date FDA Received: 07/01/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention