MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ECHELON CONTOUR W/ GREEN RELOAD; STAPLE, IMPLANTABLE

Model Number GCS40G

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

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

Event Date 05/17/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4); date sent: 6/2/2023; batch # unk; 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.The manufacturing records were reviewed and the manufacturing/packaging criteria were met prior to the release of this lot.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 low anterior resection procedure that when surgeon was transecting the sigmoid colon with the device, after the stapler was fired with the green reload, the yellow plastic part of the cartridge stapled and remained on the colon.He had to finagle the stapler off the colon.Another device was used distally.It transect a new piece of colon in order to remove the yellow plastic piece of stapler that was stapled into the colon.No patient consequence, just that the surgeon had to staple more tissue than he wished.

Manufacturer Narrative

(b)(4).Date sent: 6/15/2023.D4: batch # 289c93.Investigation summary: the product was returned for evaluation.Visual inspection and functional testing were conducted on the returned device.Visual analysis of the returned sample determined that the gcs40g device was received with no apparent damaged and with a reload present.The reload was received void of staples, the drivers and knife recessed below the cartridge deck, the anvil and washer detached/missing.The ledge of the lockout showed no indentations.The device was tested for functionality with a test reload and it fired, cut, and formed the staples as intended.The cut line and the staple line were completed and the staples meet the staple form release criteria.It should be noted that to reload the device insert the new reload into the metal housing and snap it into position.The tracks on each side of the reload should be used as guides to align the reload within the jaws of the instrument.When the reload is properly aligned, push the reload into the instrument until it is fully seated.Remove the staple retainer.Check that the reload is held firmly within the jaws.If the reload is removed from the device, whether the reload is spent or not, and if the staple retainer has already been removed from the reload, the reload cannot be reloaded into the device.Please reference the instructions for use for additional information.As part of ethicon endo surgery¿s quality process, all devices are manufactured, inspected, and released to approved specifications.A manufacturing record evaluation was performed for the finished device batch number 289c93, and no non-conformances were identified.

Manufacturer Narrative

(b)(4) date sent: 10/5/2023 additional information was requested, and the following was obtained: were there any metal pieces noted with yellow washer fallen off during reload installation or prior to firing? none noted were the yellow washer and any other components disposed off? the yellow washer was attached to the specimen and sent to pathology.

Manufacturer Narrative

(b)(4).Date sent: 4/9/2024.Additional information: the device was sent to cincinnati for additional evaluation.Upon receipt in the cincinnati pi lab, a detailed visual examination of the device was performed by design and quality engineering.Visual inspection of the device found that the returned device loaded with reload, arrived without anvil and washer.The device was shipped to the customer with a reload pre-installed indicating the most likely scenario that could lead to reported failure is that the customer removed the reload, and removed the red staple retainer and all metal parts, including the yellow washer, then reinstalled it without the anvil plate or knife guide pin, subsequently closing and firing the device, embedding the staples into the washer and cutting the tissue.

• Brand Name: ECHELON CONTOUR W/ GREEN RELOAD
• 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: 17049870
• MDR Text Key: 316411620
• Report Number: 3005075853-2023-03724
• Device Sequence Number: 1
• Product Code: GDW
• UDI-Device Identifier: 10705036027508
• UDI-Public: 10705036027508
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K200420
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GCS40G
• Device Catalogue Number: GCS40G
• Device Lot Number: 289C93
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/03/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/21/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1