MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ECHELON 3000 60MM STANDARD; STAPLE, IMPLANTABLE

Model Number ECH60S

Device Problems Unintended Ejection (1234); Difficult to Open or Close (2921)

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

Event Date 05/15/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Date sent: 6/9/2023.D4: batch # x96e9d.A manufacturing record evaluation was performed for the finished ech60s with lot/batch number x96e9d, and no non-conformances were identified.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

It was reported that during a lung resection the reload fell out of the device into the patient cavity.It was retrieved.Upon inspection it was discovered the device would not fully close.A new device was used to complete the case with no patient consequences.

Manufacturer Narrative

(b)(4).Date sent: 8/11/2023.Investigation summary: the product was returned to ethicon endo-surgery for evaluation.Visual inspection was conducted on the returned device.Visual analysis of the returned sample determined that one ech60s device was returned with the anvil bent upwards, the handle shrouds partially opened, with a gst60t reload present.The reload was received unfired.The handle shrouds were removed and were found to be damaged.As additional testing, the device was tested for functionality in the straight position with a returned reload and achieved its complete firing sequence without any difficulties.The returned reload was placed and removed with no issues noted during functional testing.  no conclusion could be reached as to what may have caused the shrouds to be damaged.It is possible that the device was clamped over an excess of tissue causing the anvil to bend and for the firing stroke and the staple form to be incomplete.Please reference the instruction for use for more information.Device history review: a manufacturing record evaluation was performed for the finished device batch number 958a57, and no non-conformances related to the reported complaint condition were identified.

• Brand Name: ECHELON 3000 60MM STANDARD
• Type of Device: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer Contact: kate karberg ; 475 calle c; guaynabo ; 3035526892
• MDR Report Key: 17097911
• MDR Text Key: 316869806
• Report Number: 3005075853-2023-03967
• Device Sequence Number: 1
• Product Code: GDW
• UDI-Device Identifier: 10705036035015
• UDI-Public: 10705036035015
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K213633
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ECH60S
• Device Catalogue Number: ECH60S
• Device Lot Number: 958A57
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2023
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/13/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ECHELON 60MM REINFORCEMENT; GST60T SINGLE PROUDUCT INSTRUMENT