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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN EEA AUTO SUTURE DST; STAPLER, SURGICAL
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COVIDIEN EEA AUTO SUTURE DST; STAPLER, SURGICAL Back to Search Results
Lot Number UNKNOWN
Device Problem Failure to Fire (2610)
Patient Problems Failure to Anastomose (1028); Tissue Damage (2104)
Event Date 11/06/2015
Event Type  Injury  
Event Description
After creating a lower colon anastomosis the surgeon applied an eea surgical stapling device to secure the anastomosis.The device was used according to manufacturer's instructions/directions.The device appeared to function properly and sounded as though it was firing.However, after the stapling device was removed, the anastomosis released and the tissues came apart.Inspection of the tissues revealed the stapler did not fire.The staples did not close to secure the anastomosis.Additional tissue from the rectum was resected to create a new anastomosis.A stapling device from a different manufacturer was obtained and utilized to secure a new anastomosis.The patient may have some bowel dysfunction because of this event.
 
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Brand Name
EEA AUTO SUTURE DST
Type of Device
STAPLER, SURGICAL
Manufacturer (Section D)
COVIDIEN
60 middletown ave.
north haven CT 06473
MDR Report Key5401250
MDR Text Key37201711
Report Number5401250
Device Sequence Number1
Product Code GAG
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 11/17/2015,12/08/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Device Operator Physician
Device Lot NumberUNKNOWN
Other Device ID Number28 MM - 4.8 MM
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA11/17/2015
Event Location Hospital
Date Report to Manufacturer11/17/2015
Initial Date Manufacturer Received Not provided
Initial Date FDA Received02/01/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Treatment
NO
Patient Outcome(s) Required Intervention;
Patient Age59 YR
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