MAUDE Adverse Event Report: DAVIS & GECK CARIBE LTD VERSAPORT PLUS; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number 179095P

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Protective Measures Problem (3015)

Patient Problems Great Vessel Perforation (2152); Blood Loss (2597); No Code Available (3191)

Event Date 02/14/2019

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter during cholecystectomy, when placing the cutting trocar, the knife of the trocar had cut the patient's aorta.The patient was hospitalized for 5 days due to the issue.There was blood loss of more than 500cc due to the product problem.The surgical time was extended for 6hrs.Due to the device problem.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter during cholecystectomy, when placing the cutting trocar, the knife of the trocar had cut the patient's aorta even though the shield indicator was on.The patient was hospitalized for 5 days due to the issue.There was blood loss of more than 500 cc due to the product problem.The surgical time was extended for 6hrs.Due to the device problem.A vascular repair was performed to resolve the issue.

• Brand Name: VERSAPORT PLUS
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): DAVIS & GECK CARIBE LTD; zona franca de san isidro; santo domingo 0101 ; DO 0101
• Manufacturer (Section G): DAVIS & GECK CARIBE LTD; zona franca de san isidro; santo domingo 0101 ; DO 0101
• Manufacturer Contact: lisa hernandez ; 60 middletown ave.; north haven, CT 06473 ; 2034925563
• MDR Report Key: 8445640
• MDR Text Key: 139618014
• Report Number: 9612501-2019-00571
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 20884521081281
• UDI-Public: 20884521081281
• Combination Product (y/n): N
• Reporter Country Code: CI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/22/2019

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2023
• Device Model Number: 179095P
• Device Catalogue Number: 179095P
• Device Lot Number: J8G2090X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/27/2019
• Initial Date FDA Received: 03/22/2019
• Supplement Dates Manufacturer Received: 04/04/2019
• Supplement Dates FDA Received: 04/22/2019
• Date Device Manufactured: 07/25/2018
• 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): Hospitalization; Required Intervention