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

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).

• Brand Name: ETHICON
• Type of Device: ECHELON FLEX POWERED PLUS STAPLER
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC; 475 calle ; guaynabo PR 00969
• MDR Report Key: 7167215
• MDR Text Key: 96469600
• Report Number: 7167215
• Device Sequence Number: 1
• Product Code: GAG
• UDI-Device Identifier: 10705036015352
• UDI-Public: (01)10705036015352
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• 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 Received: 12/28/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: PSEE45A
• Device Lot Number: P91L4K
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/12/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/30/2017
• Distributor Facility Aware Date: 11/08/2017
• Event Location: Hospital
• Date Report to Manufacturer: 11/09/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: BATCH NUMBER ON RELOAD (STAPLERS) 956M3F.; OTHER IDENTIFYING NUMBERS ON THIS EQUIPMENT: A000441P00, (B)(4) .; STAPLER BATCH #P55J7E.
• Patient Outcome(s): Death; Life Threatening; Required Intervention
• Patient Age: 68 YR