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

Model Number PLEE60A

Device Problems Device Difficult to Setup or Prepare (1487); Defective Component (2292)

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

Event Date 10/19/2020

Event Type  malfunction  

Event Description

Surgical technician reported the echelon powered stapler would not "seat loads." the tech was unable to properly load the stapler as the jaw appeared to malfunction.The device was not used on a patient.

Event Description

Surgical technician reported the echelon powered stapler would not "seat loads." the tech was unable to properly load the stapler as the jaw appeared to malfunction.*the device was not used on a 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: 11214167
• MDR Text Key: 228169826
• Report Number: 11214167
• Device Sequence Number: 1
• Product Code: GDW
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial,Followup
• Report Date: 01/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: PLEE60A
• Device Catalogue Number: PLEE60A
• Device Lot Number: U94V6X
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/15/2021
• Event Location: Hospital
• Date Report to Manufacturer: 01/22/2021
• Patient Sequence Number: 1