MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC ECHELON FLEX; STAPLE, IMPLANTABLE

Model Number PVE35A

Device Problem Separation Failure (2547)

Patient Problems Death (1802); Hemorrhage/Bleeding (1888); Injury (2348)

Event Date 03/04/2019

Event Type  Death  

Event Description

Using stapler ton the right hepatic vein- stapler did not detach from the vein and ripped the vein causing massive bleeding.

• Brand Name: ECHELON FLEX
• Type of Device: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC; route 22 west; p.o. box 151; somerville NJ 08876
• MDR Report Key: 8443190
• MDR Text Key: 139544398
• Report Number: 8443190
• Device Sequence Number: 1
• Product Code: GDW
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PVE35A
• Device Catalogue Number: PVE35A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/14/2019
• Event Location: Hospital
• Date Report to Manufacturer: 03/22/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 11680 DA