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

Catalog Number	GLC100
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/21/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an unknown procedure the glc100 device was activated during the procedure.During the use of the third reload, a component detached from the device, resulting in device malfunction and preventing further use of the device.
Additional Manufacturer Narrative
(b)(4).Date sent: 9/15/2026.D4 batch # 656d12.D4: udi: the expiration date is currently not available.Therefore, the full udi is currently not available.Photo analysis: th is is an analysis of a photo submitted for evaluation.During the visual analysis, the following was observed: the photo shows the shroud of device on the batch area (656d12 - 0074) and the part that support the anvil clamp doble pin was noted broken.Based on the photo the event described is confirmed, however no conclusion or root cause could be determined.Hands on device analysis may provide the additional evidence necessary to confirm the root cause of the reported event.Because the instrument was not returned our evaluation is limited.A manufacturing record evaluation was performed for the finished device batch number 656d12 , and no non-conformances were identified.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.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: could you please specify what was the component that was detached from the device? was there any missing part of the anvil? or, any missing part of the firing trigger? or, any missing part from the handle? if other, please specify.Is the current patient status known? was there any patient consequence or change in the post-operative care of the patient as a result of the event? (extended hospital stay, readmission, re-operation, etc.).

• Brand Name: Echelon Linear Cutter
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): 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: 50772111
• Report Number: 3005075853-2026-07531
• Device Sequence Number: 18795327
• Product Code: GAG
• UDI-Device Identifier: 10705036030898
• UDI-Public: 10705036030898
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• PMA/510(K) Number: K223760
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Type of Report: Initial
• Report Date (Section B): 09/15/2026

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: GLC100
• Device Lot Number: 656D12-0074
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 09/07/2026
• Initial Report FDA Received Date: 09/15/2026
• 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
• Patient Sex: Unknown