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

Model Number PSEE45A

Device Problems Failure to Advance (2524); Failure to Fire (2610)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/24/2020

Event Type  malfunction  

Event Description

A 45 mm laparoscopic stapler only fired approximately 1 cm, and surgeon reported it would not fire any farther.Battery was turned 180 degrees and manual release was completed.Stapler would not advance.Fda safety report id# (b)(4).

• Brand Name: ECHELON FLEX POWERED PLUS STAPLER
• Type of Device: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY INC.; cincinnati OH 45242
• MDR Report Key: 10619611
• MDR Text Key: 210005151
• Report Number: MW5097036
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 09/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2023
• Device Model Number: PSEE45A
• Device Lot Number: U94N74
• 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: 67 YR