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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN COVIDIEN COVIDIEN STAPLER WITH DTS SERIES

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COVIDIEN COVIDIEN COVIDIEN STAPLER WITH DTS SERIES Back to Search Results
Catalog Number EEA31
Device Problems Difficult to Remove (1528); Physical Resistance (2578)
Patient Problems Failure to Anastomose (1028); Hemorrhage/Bleeding (1888)
Event Date 09/15/2017
Event Type  Injury  
Event Description

During a laparoscopic total colectomy, covidien circular stapler was fired and removal of the stapler was difficult as some resistance was met. The staple was eventually withdrawn, however, the anvil was retained in the lumen. In addition, some bleeding occurred in the mesentery and was controlled by clips. To remove the anvil, the flexible sigmoidoscope was introduced and an endoscopic net was used without success. An endo loop was introduced into the rectum without success as well. Finally, using a biopsy forceps, the donut was grasped and the anvil removed guided by laparoscopy. Patient was taken back to surgery three days later with anastomotic leak.

 
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Brand NameCOVIDIEN
Type of DeviceCOVIDIEN STAPLER WITH DTS SERIES
Manufacturer (Section D)
COVIDIEN
mansfield MA
MDR Report Key6922121
MDR Text Key88863503
Report NumberMW5072635
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 Voluntary
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial
Report Date 10/04/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/06/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberEEA31
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer?
Is The Device Single Use?
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient TREATMENT DATA
Date Received: 10/06/2017 Patient Sequence Number: 1
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