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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC N/A; ENDOSCOPIC TISSUE APPROXIMATION DEVICE
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ETHICON ENDO-SURGERY, LLC N/A; ENDOSCOPIC TISSUE APPROXIMATION DEVICE Back to Search Results
Model Number ECS33A
Device Problems Leak/Splash (1354); Failure to Form Staple (2579)
Patient Problem Insufficient Information (4580)
Event Date 02/16/2021
Event Type  malfunction  
Event Description
The ethicon eea stapler was placed through the rectum after the rectum had been dilated.An eea stapled anastomosis was then performed with 2 complete doughnuts.However, when the leak test was performed there was a large leak.The anterior wall of the staple line was open.The anastomosis was then taken down completely and the staple lines removed.A double purse-string anastomosis was then attempted robotically with an eea stapler.Upon evaluation of this second attempt, the doughnuts were not intact and there was also a leak on the leak test.The decision was made to open.
 
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Brand Name
N/A
Type of Device
ENDOSCOPIC TISSUE APPROXIMATION DEVICE
Manufacturer (Section D)
ETHICON ENDO-SURGERY, LLC
475 calle c
guaynabo PR 00969
MDR Report Key11618778
MDR Text Key243986997
Report Number11618778
Device Sequence Number1
Product Code OCW
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Nurse
Type of Report Initial
Report Date 04/02/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/06/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberECS33A
Device Catalogue NumberECS33A
Device Lot NumberU94J20
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/02/2021
Event Location Hospital
Date Report to Manufacturer04/06/2021
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age17155 DA
Patient Weight142
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