ECHELON CIRCULAR

Description of Event or Problem

It was reported that a patient bowel resection was done by Doctors. Patient was taken back 4 days later to the operating room for an anastomotic leak. At the time of the take back surgery we found the staple line had completely fallen apart but the tissue was healthy; no infection or necrosis.

Additional Manufacturer Narrative

(b)(4).Date Sent: 7/31/2026.D4 Batch #: Unknown.D4: UDI: As the lot number for the device involved in the event was not provided, the full UDI is currently not available.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 is the lot/batch number?Were there any issues experienced with the device in the initial surgical procedure?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?Was a complete transection of the white breakaway washer visually confirmed?Were the donuts inspected? If so, please describe.Were there any issues noted with staple formation? If so, please describe the shape and location.How many days postoperative did the leak occur?How was the leak identified?What was observed at the site of the leak upon reoperation?How was the leak addressed?What is the current status of the patient?An Analysis of the product could not be performed since a physical sample was not received for evaluation.An evaluation of the manufacturing record could not be performed as the required product Identification number was not provided to complete the evaluation. As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications. 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.