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U.S. Department of Health and Human Services

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

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COVIDIEN LLC COVIDIEN 29MM EEA STAPLER TRIEEA28XT MEDTRONIC / COVIDIEN EEA STAPLER Back to Search Results
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.

 
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Brand NameCOVIDIEN 29MM EEA STAPLER TRIEEA28XT
Type of DeviceMEDTRONIC / COVIDIEN EEA STAPLER
Manufacturer (Section D)
COVIDIEN LLC
15 hampshire st.
mansfield MA 02048
MDR Report Key11518120
MDR Text Key241073767
Report Number11518120
Device Sequence Number1
Product Code GAG
Combination Product (Y/N)
Reporter Country CodeUS
Number of Events Reported1
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
0 PatientS WERE Involved in the Event:
Date FDA Received03/18/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device LOT NumberPOC1374Y
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer03/03/2021
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA02/24/2021
Distributor Facility Aware Date02/24/2021
Event Location Hospital
Was Device Evaluated By Manufacturer?
Is The Device Single Use?
Is this a Reprocessed and Reused Single-Use Device? Yes
Type of Device Usage

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