MAUDE Adverse Event Report: COVIDIEN VPORT PLUS 15MM TROCAR W/FIX CAN X3; DISPOSABLE SURGICAL ACCESS DEVICE

Model Number 179078PF

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/28/2015

Event Type  malfunction  

Event Description

Procedure: lap sleeve gastrectomy.The patient status and patient information is not available.However, the patient had no negative results due to this occurrence.

Manufacturer Narrative

(b)(4) opened to capture multiple complaints.

Event Description

According to the reporter: the rubber seal on the snap on 5mm adapter hub is coming detached and is as a result being pushed into the patient.I was told that this has happened multiple times in the past as well.Product was thrown away.There was no patient injury.The rubber seal on the 5mm adapter fell into the patient but was removed.There was no unanticipated tissue loss.The incision was not extended by more than one inch.There was no unanticipated blood loss of 500cc or more.Surgery time was not delayed by more than 30 minutes.

• Brand Name: VPORT PLUS 15MM TROCAR W/FIX CAN X3
• Type of Device: DISPOSABLE SURGICAL ACCESS DEVICE
• 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: 4911665
• MDR Text Key: 17548442
• Report Number: 9612501-2015-00405
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062326
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 179078PF
• Device Catalogue Number: 179078PF
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/30/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1