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

Catalog Number GCS40G

Device Problems Failure to Cut (2587); Difficult to Open or Close (2921)

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

Event Date 01/01/2024

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Date sent 3/29/2024.D4 batch # unk.B3: only event year known: 2024.An analysis of the product could not be performed since a physical sample was not received for evaluation.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.However, if the product is received at a later date, the investigation will be updated as applicable.No lot or batch number was provided therefore a device history could not be done.Additional information was requested, and the following was obtained: 1.Was the device difficult to close on the tissue? yes (in the first attempt to close).2.Was the device difficult to fire? unknown.3.Did the device cut? yes.4.If not, please provide more details of device malfunction? n/a.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 the device is pre-closed, then closed across the colon.Upon trying to close the gcs40g, the surgeon identifies that further dissection is required to reduce tissue volume within the device.The device is removed from the patient and further dissection is performed.Upon reintroducing the stapler across the colon and closing, the stapler jams and is prevented from closing.There were no patient consequences.

• Brand Name: ECHELON CONTOUR W/ GREEN RELOAD
• Type of Device: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer Contact: kate karberg ; 475 calle c; guaynabo ; PR ; 3035526892
• MDR Report Key: 19003020
• MDR Text Key: 339040610
• Report Number: 3005075853-2024-02477
• Device Sequence Number: 1
• Product Code: GDW
• UDI-Device Identifier: 10705036027508
• UDI-Public: 10705036027508
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: K200420
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: GCS40G
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/14/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1