MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ECHELON ENDOPATH; STAPLE, IMPLANTABLE

Catalog Number	GST45T
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Fistula (1862)
Date of Event	01/06/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a gastroplasty there was an occurrence of a fistula in patient during a sleeve surgery at the firing of the first staple load.
Additional Manufacturer Narrative
(b)(4).Date sent 4/2/2026.D4 batch # unk.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.The manufacturing records were reviewed and the manufacturing/packaging criteria were met prior to the release of this lot.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: was the firing sequence started but not completed? if yes: - did the device deliver any staples? - if yes, were there any issues noted with staple formation at any point throughout the care of the patient? if so, please describe the shape and location - was the staple line complete? - did the device cut? - if yes, was the cut line complete? - if yes, was there any issue with the cut line - was there any difficulty opening the device jaws? - if yes, what steps were taken to open the jaws.- if the jaws could not be opened, how was the device removed.- describe the sequence of events prior to firing the stapler.- describe the fistula in size, location, and tissue involved.- was the fistula found intraoperatively or postoperatively? - if so, how was the fistula addressed intraoperatively? - if so, how was the fistula addressed postoperatively? - was the fistula at the site where the tissue was transected? - what is the current status of the patient? - are there any pictures or videos available? 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 ENDOPATH
• Common Device Name: 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: orla o'mahony ; 475 calle c; guaynabo ; * ; 3035526892
• MDR Report Key: 24764760
• Report Number: 3005075853-2026-02440
• Device Sequence Number: 9248776
• Product Code: GDW
• UDI-Device Identifier: 10705036014911
• UDI-Public: (01)10705036014911(17)261231(10)810C90(21)
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K163454
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/02/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: GST45T
• Device Lot Number: 810C90
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/19/2026
• Initial Report FDA Received Date: 04/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/19/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 43 YR
• Patient Sex: Unknown