MAUDE Adverse Event Report: COVIDIEN ENDO GIA ULTRA UNIVERSAL STAPLER 12MM SHORT; STAPLER, SURGICAL

Model Number EGIAUSHORT

Device Problem Mechanical Jam (2983)

Patient Problem No Code Available (3191)

Event Date 02/07/2019

Event Type  malfunction  

Event Description

During vats procedure, staple device malfunctioned.Stapler placed on the lung tissue with the intent to resect it but the stapler would not release after being fired.Another type of stapler had to be used to resect the tissue safely.Surgery was prolonged, but stay was not.No harm to pt.

• Brand Name: ENDO GIA ULTRA UNIVERSAL STAPLER 12MM SHORT
• Type of Device: STAPLER, SURGICAL
• Manufacturer (Section D): COVIDIEN
• MDR Report Key: 8386121
• MDR Text Key: 137794818
• Report Number: MW5084581
• Device Sequence Number: 1
• Product Code: GAG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 02/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2023
• Device Model Number: EGIAUSHORT
• Device Catalogue Number: (01) 108874523003536
• Device Lot Number: P8H1324X
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• 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: 58 YR