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

Model Number PVE35A

Device Problems Separation Failure (2547); Firing Problem (4011)

Patient Problem Insufficient Information (4580)

Event Date 07/02/2021

Event Type  malfunction  

Event Description

Stapler was clamped on the pulmonary artery and was engaged.Did not cut or lay down staples.Then it would not unclamp.Surgeon used safety override to release from patient.

• Brand Name: ECHELON FLEX
• Type of Device: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC; 475 calle c; guaynabo PR 00969
• MDR Report Key: 12202276
• MDR Text Key: 262666133
• Report Number: 12202276
• Device Sequence Number: 1
• Product Code: GDW
• UDI-Device Identifier: 10705036014584
• UDI-Public: (01)10705036014584
• 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: 07/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PVE35A
• Device Catalogue Number: PVE35A
• Device Lot Number: V94T0N
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/07/2021
• Event Location: Hospital
• Date Report to Manufacturer: 07/21/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1