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

Model Number 179078PF

Device Problem Loose or Intermittent Connection (1371)

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

Event Type  malfunction  

Event Description

According to the reporter: 5mm seal on reducer cap is failing/loosening/falling off, causing pneumo leak on instrument insertion/withdrawal.No patient impact.Opened new unit, continued case.

Manufacturer Narrative

(b)(4).

• 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: 4882718
• MDR Text Key: 6042372
• Report Number: 9612501-2015-00379
• 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
• Report Date: 06/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2015
• 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
• Date Manufacturer Received: 06/23/2015
• 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