MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ECHELON FLEX 45 STANDARD; STAPLE, IMPLANTABLE

Model Number EC45A

Device Problems Failure to Fire (2610); Device Markings/Labelling Problem (2911); Packaging Problem (3007); Firing Problem (4011)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/21/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch #:u5c81d.Attempts have been made to retrieve the device.To date, the device has not been returned.If the device or further details are received at a later date, a supplemental medwatch will be sent.A manufacturing record evaluation was performed for the finished device and the manufacturing criteria were met prior to the release of this lot/batch.

Event Description

It was reported that during an endoscopic radical resection of lung cancer surgery, the device would not fire on the first firing.The surgeon noted that the physical object was not in conformity with the packing.The packaging was for an ec45a, but the device was actually an ec60a.Changed to another device to complete the procedure.There was no patient consequence reported.No additional information could be provided.

Manufacturer Narrative

(b)(4).Date sent: 12/8/2020.D4: batch#: u5c81d.Investigation summary: the analysis results found that the ec60a device instead of an ec45a device was returned with no apparent damage.In addition, the tyvek was returned along with the device.Further analysis showed that the tyvek belong to an ec45a device.An ecr45g reload no loaded on the device was received fully fired.However, a reload 45mm cannot be fired with a device ec60a.The device was tested for functionality in the articulated position with a test reload 60mm and achieved its complete firing sequence without any difficulties.The staple line and cut line were complete and the staples meet the staple release criteria.As part of our quality process, the manufacturing records of this lot was reviewed, and the manufacturing standards were met prior to the release of this lot.This defect has been correlated to the manufacturing process.It should be noted that as part of our quality process all devices are manufactured, inspected, and released to approved specifications.

• Brand Name: ECHELON FLEX 45 STANDARD
• Type of Device: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 10714579
• MDR Text Key: 212495274
• Report Number: 3005075853-2020-05449
• Device Sequence Number: 1
• Product Code: GDW
• UDI-Device Identifier: 10705036001676
• UDI-Public: 10705036001676
• Combination Product (y/n): N
• PMA/PMN Number: K051002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Type of Report: Initial,Followup
• Report Date: 09/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/13/2023
• Device Model Number: EC45A
• Device Catalogue Number: EC45A
• Device Lot Number: U94A0J
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2020
• Date Manufacturer Received: 11/10/2020
• Patient Sequence Number: 1
• Treatment: ECR45G.