MAUDE Adverse Event Report: COVIDIEN VERSAPORT V2 FIXATION CANNULA 12MM; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number 179096PF

Device Problem Insufficient Information (3190)

Patient Problems Complaint, Ill-Defined (2331); Injury (2348)

Event Date 07/09/2015

Event Type  Injury  

Event Description

Procedure: colorectal.According to the reporter: in re-introducing the device, the aorta got damaged and needed intervention with blood transfusion.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

(b)(4).

• Brand Name: VERSAPORT V2 FIXATION CANNULA 12MM
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): COVIDIEN; zona franca de san isidro; carretara san isidro km17; santo domingo ; DR
• Manufacturer (Section G): COVIDIEN; zona franca de san isidro; carretara san isidro km17; santo domingo ; DR
• Manufacturer Contact: sharon murphy ; 60 middletown ave; north haven, CT 06473 ; 2034925267
• MDR Report Key: 4960370
• MDR Text Key: 6640721
• Report Number: 9612501-2015-00457
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K062326
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/31/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2020
• Device Model Number: 179096PF
• Device Catalogue Number: 179096PF
• Device Lot Number: J5B1188X
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/31/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other