MAUDE Adverse Event Report: COVIDIEN / /MEDTRONIC, INC EEA CIRCULAR STEPLER WITH TRI-STAPLE TECHNOLOGY; STAPLER, SURGICAL

Lot Number P9H0992Y

Device Problems Leak/Splash (1354); Misfire (2532)

Patient Problem Insufficient Information (4580)

Event Date 08/24/2020

Event Type  malfunction  

Event Description

Eea stapler misfire which led to leak per dr.Fda safety report id# (b)(4).

• Brand Name: EEA CIRCULAR STEPLER WITH TRI-STAPLE TECHNOLOGY
• Type of Device: STAPLER, SURGICAL
• Manufacturer (Section D): COVIDIEN / /MEDTRONIC, INC
• MDR Report Key: 10521042
• MDR Text Key: 206767384
• Report Number: MW5096550
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 09/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: P9H0992Y
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 73 YR