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

Catalog Number PLEE60A

Device Problems Defective Component (2292); Failure to Fire (2610)

Patient Problem Insufficient Information (4580)

Event Date 07/16/2021

Event Type  malfunction  

Event Description

After using the stapler 5 times, on the 5th time, the md stated, "this stapler is defective, it didn't fire correctly." a new stapler was opened.

• 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: 12286857
• MDR Text Key: 265385398
• Report Number: 12286857
• 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
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 07/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: PLEE60A
• 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: 07/26/2021
• Event Location: Hospital
• Date Report to Manufacturer: 08/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 29200 DA
• Patient Weight: 68