MAUDE Adverse Event Report: COVIDIEN/MEDTRONIC EGIAVSHORT; STAPLER

Model Number EGIAVSHORT

Device Problem Failure to Cut (2587)

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

Event Date 02/23/2017

Event Type  malfunction  

Event Description

The surgeon was using the covidien 45 mm purple load for a wedge resection on the patient's left lung and the device failed to complete the cut.A new handle and a new load were opened, the rep called and informed as well.The rep suggested a 45 mm black load for a thicker tissue to be used next.It was unclear if the issue was the load or the handle.

• Brand Name: EGIAVSHORT
• Type of Device: STAPLER
• Manufacturer (Section D): COVIDIEN/MEDTRONIC; 710 medtronic pkwy.; minneapolis MN 55432 5604
• MDR Report Key: 6423891
• MDR Text Key: 70644558
• Report Number: MW5068565
• Device Sequence Number: 1
• Product Code: GAG
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/17/2017
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2021
• Device Model Number: EGIAVSHORT
• Device Catalogue Number: N6J0350KX
• Device Lot Number: P6E0208X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• 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 Age: 71 YR