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

Catalog Number ECH60L

Device Problems Failure to Form Staple (2579); Failure to Cut (2587); No Apparent Adverse Event (3189)

Patient Problems Hemorrhage/Bleeding (1888); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/01/2023

Event Type  malfunction  

Event Description

It was reported that during bariatric sleeve.First staple fire only went a little bit and locked out.Second load fired all the way but only cut along one side of device causing excessive bleeding for patient.Used a third stapler to finish procedure and had to re-do previous misfires.No patient harm after bleeding.

Manufacturer Narrative

(b)(4).Date sent: 11/14/2023.D4: batch # a9d75k b3: date of event is 2023, event day and month unknown.Captured as on (b)(6) 2023.Additional information was requested, and the following was obtained: "please clarify if the device only stapled on one side? if yes, what side was the stapler fired and deployed the staples, but the staple legs did not close are any pictures available? yes ¿ all have been sent to the rapid response team (steve miltenberger) what color cartridge was used? black was buttress used? if so, what kind? gore seamguard was the first firing of the reload locked on tissue? no , it only fired a few mm¿s and then stopped what trouble shooting steps were taken during this event? home button was pressed, returning the blade home and then staple reload was discarded, new one inserted how was the post-op bleeding identified? not identified how many days postoperative was the bleeding identified? not identified what was the total estimated blood loss (ml)? n/a was a transfusion required? no how was the bleeding addressed? n/a what was the pre and postoperative anti-coagulant and pain management protocol? n/a was the bleeding intraluminal or extraluminal? n/a" an evaluation of the manufacturing record could not be performed as the required product identification number was not provided to complete the evaluation.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.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.

Manufacturer Narrative

(b)(4), date sent: 12/18/2023.D4: batch # 433c69.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 ech60l device was returned with a dent in the nozzle and with a gst60t reload fully fired loaded on the device.Upon evaluation of the reload, the reload was returned with no apparent damage and the sled is not damaged.The device was tested for functionality in the straight position with a test reload and achieved its complete firing sequence.However, the staples were partially formed.After further evaluation, the ct scan analysis showed that the knife wings appeared to be broken.In order to verify the condition of the internal components, the device was disassembled.Upon disassembling, it was observed the knife wings were broken from the knife and the knife was noted to be buckled.The damage to the knife is consistent with the device being clamped over an excess of tissue.If the firing continues the knife will remain inside the guide, and as the knife is attempting to pull the anvil towards the reload to form the staples it will result in the damage observed on the knife.Please reference the instruction for use for more information.Based on the information currently available, a product issue was identified during the investigation of the sample received.The damage to the nozzle is potentially related to a manufacturing process.This product issue will be addressed through ethicon endo surgery¿s quality system.Device history review a manufacturing record evaluation was performed for the finished device batch number 433c69, and no non-conformances were identified.

• Brand Name: ECHELON 3000 60MM LONG
• 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: 18130586
• MDR Text Key: 328038716
• Report Number: 3005075853-2023-08425
• Device Sequence Number: 1
• Product Code: GDW
• UDI-Device Identifier: 10705036034988
• UDI-Public: 10705036034988
• 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: 12/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ECH60L
• Device Lot Number: 433C69
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2023
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/24/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1