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

Model Number	179095P
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Protective Measures Problem (3015)
Health Effect - Clinical Codes	Great Vessel Perforation (2152); Blood Loss (2597); No Code Available (3191)
Date of Event	02/14/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem 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.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem 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
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): DAVIS & GECK CARIBE LTD; zona franca de san isidro; santo domingo 0101 ; DO 0101
• MDR Report Key: 8445640
• Report Number: 9612501-2019-00571
• Device Sequence Number: 14174886
• Product Code: GCJ
• UDI-Device Identifier: 20884521081281
• UDI-Public: 20884521081281
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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
• Initial Date Received by Manufacturer: 02/27/2019
• Supplement Date Received by Manufacturer: 04/04/2019
• Initial Report FDA Received Date: 03/22/2019
• Supplement Report FDA Received Date: 04/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention