MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, INC. ECHELON FLEX POWERED PLUS STAPLER / LAPAROSCOPIC LINEAR CUTTER; STAPLE, IMPLANTABLE

Model Number PLEE60A

Device Problems Crack (1135); Activation, Positioning or Separation Problem (2906)

Patient Problem Insufficient Information (4580)

Event Date 12/07/2020

Event Type  malfunction  

Event Description

When attempting to fire stapler, the activation handle would not engage.The device was then released and a yellow piece of plastic dropped from the handle area of the device.The underside of the plastic housing was also noted to be cracked.Fda safety report id# (b)(4).

• Brand Name: ECHELON FLEX POWERED PLUS STAPLER / LAPAROSCOPIC LINEAR CUTTER
• Type of Device: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, INC.
• MDR Report Key: 10991552
• MDR Text Key: 221250364
• Report Number: MW5098307
• Device Sequence Number: 1
• Product Code: GDW
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2023
• Device Model Number: PLEE60A
• Device Catalogue Number: PLEE60A
• Device Lot Number: U95061
• Was Device Available for Evaluation?: Yes
• 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 Age: 73 YR