MAUDE Adverse Event Report: MEDTRONIC EEA; STAPLER, SURGICAL

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Inflammation (1932); Perforation (2001)

Event Date 04/25/2019

Event Type  Injury  

Event Description

Patient arrived to the operating room for a planned robotic-assisted, laparoscopic low anterior bowel resection.Two days later: patient discharged to home.Two days later: patient arrived to the hospital as a direct-admit from doctor's office secondary to a ct finding of inflammation around anastomosis with possible leak.Abx.Started.Two days later: to operating room for a laparoscopic hartmann's procedure with end-colostomy.Perforation was found at the end-to-end.Four days later: patient discharged home.

• Brand Name: EEA
• Type of Device: STAPLER, SURGICAL
• Manufacturer (Section D): MEDTRONIC; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 8739222
• MDR Text Key: 149352993
• Report Number: 8739222
• Device Sequence Number: 1
• Product Code: GAG
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 05/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/14/2019
• Event Location: Hospital
• Date Report to Manufacturer: 06/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 19345 DA
• Patient Weight: 85