MAUDE Adverse Event Report: COVIDIEN EEA AUTOSUTURE CIRCULAR STAPLER; STAPLER, SURGICAL

Catalog Number EEAXL25

Device Problems Detachment of Device or Device Component (2907); Device Fell (4014)

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

Event Date 05/06/2019

Event Type  malfunction  

Event Description

Upon firing the staple device, it was noticed that the tip of the staple had fallen off inside the pt.It was unable to be used successfully.All the parts were retrieved from the pt without injury.A second device malfunctioned.A third stapler was opened and fired correctly.Fda safety report id# (b)(4).

• Brand Name: EEA AUTOSUTURE CIRCULAR STAPLER
• Type of Device: STAPLER, SURGICAL
• Manufacturer (Section D): COVIDIEN
• MDR Report Key: 8597093
• MDR Text Key: 144686567
• Report Number: MW5086508
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 05/07/2019
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/30/2022
• Device Catalogue Number: EEAXL25
• Device Lot Number: P7L0183KX
• Was Device Available for Evaluation?: Yes
• 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: 45 YR