MAUDE Adverse Event Report: Ethicon Endo-Surgery, LLC. ECHELON; STAPLE, IMPLANTABLE

Catalog Number	ECH60S
Medical Device Problem Codes	Ejection Problem (4009); Separation Problem (4043)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/10/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a nephrectomy procedure, they were able to reload and made a first fire and they took the reload out.And then when they tried to reload again, the reload wasn't sliding down into it.The tech and surgeons tried to do it but they still can't put the reload in so they had to open up another stapler.After the case was over, the sales rep observed the staplers that worked and did not worked.The stapler that did not work looked like there's a piece that was supposed to be beneath another piece that had popped out and was now on top of it on the reload jaw or a metal part of the reload was stuck in the reload jaw, compared to the stapler that worked supposed to be all flat.No patient consequences.No additional information provided.
Additional Manufacturer Narrative
(b)(4) date sent: 9/24/2026 d4: batch #unk 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.H4: the device manufacture date is currently not available.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 lot/batch was not provided; therefore, the manufacturing records evaluation could not be performed.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.

• Brand Name: ECHELON
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): Ethicon Endo-Surgery, LLC.; 475 calle c; guaynabo 00969 ; PR 00969
• Manufacturer (Section G): Ethicon Endo-Surgery, LLC.; 475 calle c; guaynabo 00969 ; PR 00969
• Manufacturer Contact: orla o'mahony ; 475 calle c; guaynabo 00969 ; PR 00969 ; +1(303)552-6892
• MDR Report Key: 50884494
• Report Number: 3005075853-2026-07960
• Device Sequence Number: 10667627
• Product Code: GAG
• UDI-Device Identifier: 10705036035015
• UDI-Public: 10705036035015
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K213633
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial
• Report Date (Section B): 09/24/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: ECH60S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/10/2026
• Initial Report FDA Received Date: 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GST60W
• Patient Sex: Unknown