MAUDE Adverse Event Report: COVIDIEN STEP SHORT; TROCAR

Catalog Number S100712

Device Problem Leak/Splash (1354)

Patient Problem No Information (3190)

Event Date 10/29/2014

Event Type  malfunction  

Event Description

During surgery, 5mm mini-step ports leaked.

• Brand Name: STEP SHORT
• Type of Device: TROCAR
• Manufacturer (Section D): COVIDIEN; 60 middletown ave.; north haven CT 06473
• MDR Report Key: 5369284
• MDR Text Key: 36033090
• Report Number: 5369284
• Device Sequence Number: 1
• Product Code: DRC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: S100712
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2015
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/16/2015
• Event Location: Hospital
• Date Report to Manufacturer: 11/16/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/15/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1