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

Catalog Number	GST60D
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Fistula (1862)
Date of Event	01/01/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported via journal article: this complaint is from a literature source.The following literature cite has been reviewed: title: routine staple-line clip reinforcement during laparoscopic distal pancreatectomy does not reduce clinically relevant pancreatic fistula: a multicenter randomized clinical trial authors: min kyu sunga, dakyum shinb, jaewoo kwonc, sang hyun shind, woohyung leea, ki byung songa, jae hoon leea, dae wook hwanga, song cheol kima citation: doi: 10.1097/js9.0000000000005534 (no pubmed citation available).This study aims to evaluate whether routine clip reinforcement reduces clinically relevant postoperative pancreatic fistula (cr-popf) incidence and whether its effect is influenced by pancreatic texture or friability.Between june 2021 and february 2025, a total of 190 adult patients undergoing elective laparoscopic distal pancreatectomy (ldp), using a linear stapler with a gold cartridge (gst60d; ethicon)were randomized 1:1 to stapled transection with metallic clip reinforcement (clip group, n = 96) using metallic clips (lt200; ethicon) or standard stapled transection alone (no-clip group, n = 94).Reported complications are: clip group and no-clip group.Linear stapler with a gold cartridge (gst60d; ethicon).N=47 clinically relevant postoperative pancreatic fistula (cr-popf).Treatment: not reported.Clip group only.Metallic clips (lt200; ethicon).N=21 clinically relevant postoperative pancreatic fistula (cr-popf).Treatment: not reported.In conclusion, routine staple-line clip reinforcement during ldp did not significantly reduce cr-popf incidence.These findings do not support its routine use in an unselected ldp population and suggest that operative efficiency may be a more relevant target for cr-popf prevention than additional technical reinforcement.
Additional Manufacturer Narrative
(b)(4).Date sent: 8/13/2026.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.This report is related to a journal article, therefore no product will be returned for analysis and the batch history records cannot be reviewed as the lot/batch number has not been provided.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 ; 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 ; PR ; +1(303)552-6892
• MDR Report Key: 50234034
• Report Number: 3005075853-2026-06584
• Device Sequence Number: 18707545
• Product Code: GDW
• UDI-Device Identifier: 10705036014690
• UDI-Public: 10705036014690
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K183435
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Literature,Health Professional
• Type of Report: Initial
• Report Date (Section B): 08/13/2026

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: GST60D
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 08/03/2026
• Initial Report FDA Received Date: 08/13/2026
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown