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

Catalog Number	GLC80
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during an unknown surgery, the main body was broken.The cartridge color was blue.Another device was used to complete the case.There were no adverse consequences to the patient.No further information is available.
Additional Manufacturer Narrative
(b)(4).Date sent: 4/6/2026.B3: exact event date unk, entered 1/1/2026 as only the year was provided.D4: batch # 362d06 investigation summary: the product was returned to ethicon endo surgery for evaluation.Visual inspection and functional testing were conducted on the returned device.Visual analysis of the returned sample determined that the glc80 was received with a broken anvil shroud and not attached to the metal anvil, missing clamp arm pivot pin and an anvil clamp dowel pin loose returned inside a plastic bag.Also, a glcr80b reload was loaded in the device.The reload returned fully fired with the swing tab in the locked position.During the visual inspection, the internal tab of the anvil shroud was broken, completely separate from the anvil half.The proximal end of the anvil shroud was reviewed and the witness marks were present.Witness marks indicate the device was mis clamped without having the device halves locked.It's possible that the pivot pins fell out when the anvil shroud was broken.No functional test was performed due to the condition of the returned device.Additionally, photos were provided and they showed the condition of the reported event.The damaged noted on the anvil shroud was confirmed and it is related to improper use of the device due to the witness marks present.Please reference the instruction for use for more information.As part of ethicon endo surgery¿s quality process, all devices are manufactured, inspected, and released to approved specifications.Device history review: a manufacturing record evaluation was performed for the finished device batch number 362d06, and no non-conformances were identified.Additional information was requested and the following was obtained: the main body was broken during joining the anvil half and the cartridge half.Functional end to end anastomosis (feea).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.

• 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: 24793900
• Report Number: 3005075853-2026-02568
• Device Sequence Number: 8858914
• Product Code: GDW
• UDI-Device Identifier: 10705036030881
• UDI-Public: (01)10705036030881(17)271130(10)362D06
• 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): 04/06/2026

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: 362D06
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/20/2026
• Initial Report FDA Received Date: 04/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/05/2024
• 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