MAUDE Adverse Event Report: MEDTRONIC BIG EASY; STAPLES

Model Number 1156603

Device Problems Break (1069); Device Operates Differently Than Expected (2913)

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

Event Date 03/03/2016

Event Type  Injury  

Event Description

Pt had a previous staple prosthesis replaced.It had failed/broken during or after previous procedure.The device is a "big easy" staple prosthesis.Dates of use: (b)(6) 2014.Diagnosis or reason for use: broken prosthesis.

• Brand Name: BIG EASY
• Type of Device: STAPLES
• Manufacturer (Section D): MEDTRONIC; jacksonville FL
• MDR Report Key: 5584306
• MDR Text Key: 42956099
• Report Number: MW5061747
• Device Sequence Number: 0
• Product Code: ETA
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2016
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/24/2021
• Device Model Number: 1156603
• Device Catalogue Number: 7114128
• Device Lot Number: 0207247969
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR
• Patient Weight: 91