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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC ETHICON ECHELON FLEX POWERED PLUS STAPLER

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ETHICON ENDO-SURGERY, LLC ETHICON ECHELON FLEX POWERED PLUS STAPLER Back to Search Results
Catalog Number PSEE45A
Device Problem Misfire (2532)
Patient Problems Cardiac Arrest (1762); Death (1802); Exsanguination (1841); Shock (2072); Perforation of Vessels (2135)
Event Date 11/08/2017
Event Type  Death  
Event Description

The patient was admitted on (b)(6) 2017 for elective surgery with general surgery service for a liver tumor. The surgery had no complications until a staple device was used to provide a cut to an isolated area to remove the remaining tumor in the liver. There was a misfiring and malfunction of the device which caused a hole in a large vessel close to the heart that resulted in intraoperative hemorrhage, shock, cardiac arrest and unexpected death despite multiple efforts to control the bleeding. Reporter's complete email (not enough space on page 1 to provide complete email): (b)(6). Sending update today to inform that the representative from the (b)(4) location picked up the sequestered device on (b)(4) 2017 in order for the manufacturer to run the device through quality control to determine why device may have malfunctioned. Report of findings to be provided to medical center in approximately 45 days from date of pick up from (b)(6).

 
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Brand NameETHICON
Type of DeviceECHELON FLEX POWERED PLUS STAPLER
Manufacturer (Section D)
ETHICON ENDO-SURGERY, LLC
475 calle
guaynabo PR 00969
MDR Report Key7167215
MDR Text Key96469600
Report Number7167215
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
Type of Report Initial
Report Date 12/26/2017,11/30/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/28/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Device Catalogue NumberPSEE45A
Device LOT NumberP91L4K
Was Device Available For Evaluation? Yes
Date Returned to Manufacturer12/12/2017
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA11/30/2017
Distributor Facility Aware Date11/08/2017
Event Location Hospital
Date Report TO Manufacturer11/09/2017
Was Device Evaluated By Manufacturer?
Is The Device Single Use?
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient TREATMENT DATA
Date Received: 12/28/2017 Patient Sequence Number: 1
Treatment
BATCH NUMBER ON RELOAD (STAPLERS) 956M3F.; OTHER IDENTIFYING NUMBERS ON THIS EQUIPMENT: A000441P00, (B)(4) .; STAPLER BATCH #P55J7E.
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