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

Catalog Number	GLC80
Medical Device Problem Codes	Material Integrity Problem (2978); Noise, Audible (3273)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/19/2026
Type of Reportable Event	Malfunction

• Brand Name: ECHELON LINEAR CUTTER
• 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: 25748774
• Report Number: 3005075853-2026-05436
• Device Sequence Number: 10413264
• Product Code: GDW
• UDI-Device Identifier: 10705036030881
• UDI-Public: (01)10705036030881(17)290630(10)196D60
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 07/08/2026

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: GLC80
• Device Lot Number: 196D60
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/22/2026
• Initial Report FDA Received Date: 07/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/22/2024
• 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
• Patient Sex: Unknown