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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC ENDOPATH CURVED INTRALUMINAL STAPLER; STAPLE, IMPLANTABLE
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ETHICON ENDO-SURGERY, LLC ENDOPATH CURVED INTRALUMINAL STAPLER; STAPLE, IMPLANTABLE Back to Search Results
Catalog Number ECS29A
Device Problem Failure to Deliver (2338)
Patient Problem Failure to Anastomose (1028)
Event Date 12/15/2015
Event Type  Injury  
Event Description
Procedure scheduled was laparoscopic hand assisted colostomy closure.While using the ethicon curved intraluminal stapler 29 mm, after firing the load, there were no staples present.This left the colon open as the stapler also cuts tissue when fired.The length of the colon after the stapler firing was too short to attempt another use of a different stapler, resulting in permanent colostomy.
 
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Brand Name
ENDOPATH CURVED INTRALUMINAL STAPLER
Type of Device
STAPLE, IMPLANTABLE
Manufacturer (Section D)
ETHICON ENDO-SURGERY, LLC
4545 creek road
cincinnati OH 45242
MDR Report Key5337741
MDR Text Key34759811
Report Number5337741
Device Sequence Number1
Product Code GDW
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 12/30/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/31/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Device Expiration Date08/31/2020
Device Catalogue NumberECS29A
Device Lot NumberM92K6Z
Other Device ID Number29MM
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/30/2015
Event Location Hospital
Date Report to Manufacturer12/30/2015
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
Patient Outcome(s) Other; Required Intervention;
Patient Age41 YR
Patient Weight108
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