ECHELON CIRCULAR

Description of Event or Problem

It was reported that during a Lower Anterior Resection procedure, the stapler was fired and a green check mark was received indicating a completed firing. Upon removal, one of the anastomotic rings was found to be left in the colon. A leak test was subsequently performed, and no bubbles were observed. The device was closed completely to the bottom of the green range, and the anvil was opened using two full counterclockwise rotations. Minimal resistance was encountered during removal. It was also noted that the white washer was not present; only a portion of the white washer remained in the anvil after removal. No patient consequences were reported.

Additional Manufacturer Narrative

(b)(4)Date Sent: 7/31/2026.D4 Batch #: 121E79.D4: UDI: The expiration date is currently not available. Therefore, the full UDI is currently not available.Attempts are being made to obtain the following information. To date, no response has been provided. If further details are received at a later date, a Supplemental MedWatch will be sent:What were the indications for surgery?Did the patient receive any preoperative chemotherapy or radiation?What healthcare professional fired the device and what is his/her experience with the device?Where in the green gap setting scale was the indicator located prior to firing (low-B, middle-B, or high-B)?Did the healthcare professional wait 15 seconds after closing the device and then retighten prior to firing?Were there any issues with device use/firing?What confirmation was received that the device completed the firing sequence?Was the green checkmark visible at the end of the firing?How many counter-clockwise revolutions of the adjusting knob were used to open the device?Was there any difficulty removing the device?Were there any issues noted with staple formation? If so, please describe the shape and location.Did any pieces fall into the patient?If yes, were they retrieved?Will all pieces be returned with the device?If no, were they discarded?The device upon which this MedWatch is based has been received, however, the evaluation is not yet complete. Any further information derived from the evaluation will be submitted in a supplemental 3500A form.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.