MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ECHELON LINEAR CUTTER 100MM; STAPLE, IMPLANTABLE

Catalog Number	GLC100
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	11/17/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Date sent: 12/12/2025.D4: batch # unk.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.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance were identified.Additional information was requested and the following was obtained: ¿ firstly, how is the patient? i¿ve asked to the surgeon but no response currently.¿ is the device and reloads available to be sent away for testing? unavailable (discard) ¿ was the bleeding identified during the surgery? or did this occur post op? if during the surgery how did the surgeon fix this? if post op, what was the consequence? eg reoperation etc.No apparent bleeding during surgery, postoperative identification and reoperation.¿ please confirm the size and reload colours used.Glc100 and glcr100b.¿ what is the surgeons experience with glc? what linear cutter did they use before glc? yes, he has used glc since (b)(6) and he used ntlc75 or tlc10 before.¿ any patient factors that may have made this case particularly challenging? i¿m waiting for the call with the surgeon on monday for other information.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.
Event or Problem Description
It was reported that during an unk procedure, the patient had an intraluminal bleeding after the surgery.The surgeon had to reoperate the patient the next day.

• Brand Name: ECHELON LINEAR CUTTER 100MM
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer Contact: orla o'mahony ; 475 calle c; guaynabo ; * ; 3035526892
• MDR Report Key: 23790098
• Report Number: 3005075853-2025-09434
• Device Sequence Number: 10477251
• Product Code: GDW
• UDI-Device Identifier: 10705036030898
• UDI-Public: (01)10705036030898(17)280131(10)439D11
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K223760
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/12/2025

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: GLC100
• Device Lot Number: 439D11
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/21/2025
• Initial Report FDA Received Date: 12/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/04/2025
• 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: GLCR100B(X2)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown