MAUDE Adverse Event Report: COVIDIEN COVIDIEN ENDO GIA; STAPLER DEVICE

Model Number EGIAUSTND

Device Problem Malposition of Device (2616)

Patient Problem No Information (3190)

Event Date 06/12/2018

Event Type  Injury  

Event Description

Endo gia stapler device did not lock the stapler reload cartridge into correct position.Would not properly lock, causing the handle to malfunction.Had to open a new stapler device and reload.

• Brand Name: COVIDIEN ENDO GIA
• Type of Device: STAPLER DEVICE
• Manufacturer (Section D): COVIDIEN
• MDR Report Key: 7605134
• MDR Text Key: 111341836
• Report Number: MW5077868
• 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: Other
• Type of Report: Initial
• Report Date: 06/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2023
• Device Model Number: EGIAUSTND
• Device Lot Number: P8B1243X
• 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 Outcome(s): Required Intervention
• Patient Age: 60 YR