MAUDE Adverse Event Report: COVIDIEN LLC COVIDIEN 29MM EEA STAPLER TRIEEA28XT; MEDTRONIC / COVIDIEN EEA STAPLER

Lot Number POC1374Y

Device Problem Insufficient Information (3190)

Patient Problem Rectal Anastomotic Leakage (4482)

Event Date 02/23/2021

Event Type  Injury  

Event Description

After medtronic 29 mm eea stapler was fired, a leak in anterior portion of the anastomosis.There was no tension or twisting on anastomosis.The anastomosis was redone.Extended operating room time by >2hrs.

• Brand Name: COVIDIEN 29MM EEA STAPLER TRIEEA28XT
• Type of Device: MEDTRONIC / COVIDIEN EEA STAPLER
• Manufacturer (Section D): COVIDIEN LLC ; 15 hampshire st. ; mansfield MA 02048
• MDR Report Key: 11518120
• MDR Text Key: 241073767
• Report Number: 11518120
• Device Sequence Number: 1
• Product Code: GAG
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: POC1374Y
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/24/2021
• Distributor Facility Aware Date: 02/24/2021
• Event Location: Hospital
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/18/2021
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Weight: 68