MAUDE Adverse Event Report: MEDTRONIC COVIDIEN MEDTRONIC; VERSASEAL TROCAR 5-8 MM

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/25/2016

Event Type  malfunction  

Event Description

During a (b)(6) 2014 surgery, an internal seal component of a trocar (medtronic covidien versaseal single-use trocar seal system) may have become dislodged in the course of an abdominal surgery and, unbeknownst to providers, entered the abdominal cavity of the patient.This was discovered during a subsequent abdominal surgery in (b)(6) 2016.

• Brand Name: MEDTRONIC
• Type of Device: VERSASEAL TROCAR 5-8 MM
• Manufacturer (Section D): MEDTRONIC COVIDIEN
• MDR Report Key: 6578213
• MDR Text Key: 75662865
• Report Number: MW5069891
• Device Sequence Number: 1
• Product Code: GCJ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/17/2017
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 50 YR