MAUDE Adverse Event Report: ETHICON ENDOSURGERY, INC. ECHELON POWERED STAPLER; STAPLER, SURGICAL

Device Problems Activation, Positioning or Separation Problem (2906); Firing Problem (4011)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 08/01/2019

Event Type  Injury  

Event Description

Surgeon performing distal pancreatectomy.A 35mm echelon powered stapler brought across the splenic vein and clamped shut.Stapler malfunctioned as it engaged to fire.Unclear if the stapler had fired or if any staples had cut the vessel.Another surgeon consulted.A 30mm ta stapler used.Pt developed post hemorrhage in pacu requiring reop.

• Brand Name: ECHELON POWERED STAPLER
• Type of Device: STAPLER, SURGICAL
• Manufacturer (Section D): ETHICON ENDOSURGERY, INC.
• MDR Report Key: 8940873
• MDR Text Key: 156018250
• Report Number: MW5089406
• Device Sequence Number: 1
• Product Code: GAG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 08/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 49 YR