MAUDE Adverse Event Report: COVIDIEN 28 MM EEA STAPLER; STAPLER, SURGICAL

Model Number 28 MM COVIDIEN STAPLER

Device Problem Activation, Positioning or Separation Problem (2906)

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

Event Date 08/07/2019

Event Type  Injury  

Event Description

Covidien 28 eea stapler fired according to instructions and the posterior wall (half) didn't take the staples requiring a hand-sewn anastomosis.This resulted in an extra hour of operation and a temporary ileostomy which otherwise would not have been needed.Fda safety report id# (b)(4).

• Brand Name: 28 MM EEA STAPLER
• Type of Device: STAPLER, SURGICAL
• Manufacturer (Section D): COVIDIEN
• MDR Report Key: 8907478
• MDR Text Key: 155031111
• Report Number: MW5089153
• 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: 08/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 28 MM COVIDIEN STAPLER
• 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): Hospitalization
• Patient Age: 65 YR
• Patient Weight: 85