MAUDE Adverse Event Report: ETHICON ETHICON ECHELON FLEX POWERED PLUS STAPLE

Lot Number P93C9G

Device Problem Failure to Fire (2610)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/20/2017

Event Type  malfunction  

Event Description

Surgeon using stapler for laparoscopic appendectomy.Worked correctly for the "blue" load, but would not fire when attempting to use the "grey" load.Scrub removed battery, replaced and tried the stapler again, but it did not work.Needed to get a new one to complete the surgery.

• Brand Name: ETHICON ECHELON FLEX POWERED PLUS STAPLE
• Type of Device: ECHELON FLEX POWERED PLUS STAPLE
• Manufacturer (Section D): ETHICON; somerville NJ 08876
• MDR Report Key: 7057449
• MDR Text Key: 92977240
• Report Number: MW5073554
• 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: Nurse
• Type of Report: Initial
• Report Date: 11/21/2017

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 Expiration Date: 07/31/2020
• Device Lot Number: P93C9G
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/24/2017
• 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: 24 YR