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

Catalog Number	GLC80
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/24/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Date sent: 5/5/2026.D4: batch # 651d42.Investigation summary.The product was returned to ethicon endo surgery for evaluation.Visual inspection was conducted on the returned device.Visual analysis of the returned sample determined that the glc80 was received with the metal anvil and the anvil insert detached from the handle shroud.Further evaluation shows the clamp arm pivot pin and the clamp dowel pin detached and returned inside a plastic bag.No reload was received.During the visual inspection, the internal tab of the anvil shroud was noted broken.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 and dowel pin fell out when the anvil shroud was broken.No functional test was performed due to the condition of the device.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 651d42, and no non-conformances were identified.Additional information was requested and the following was obtained: after the first stapling, the echelon clip broke at the stapling mechanism.A plastic tie also split.Two small metal fragments detached and fell into the surgical field.These fragments were recovered.The incident necessitated the resumption of the anastomosis, resulting in a lengthening of the operative time and the recovery time.No other clinical consequences were observed in the patient.Post-operative care was not changed.During the operation, after the first stapling the echelon clamp broke.Two small pieces of metal fell.A plastic tie has cracked.For the patient, a delay in taking charge occurred, and the anastomosis had to be repeated.Increasing all the risks associated with this operation.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, after the first stapling the echelon clamp broke.The two small metal pieces fell.A plastic tie has cracked.The use was made according to the manufacturer¿s recommendations by an experienced surgeon.The anastomosis had to be redone.

• 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: 25086855
• Report Number: 3005075853-2026-03426
• Device Sequence Number: 10533061
• Product Code: GDW
• UDI-Device Identifier: 10705036030881
• UDI-Public: (01)10705036030881(17)280731(10)686D29
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/05/2026

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: 686D29
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/21/2026
• Initial Report FDA Received Date: 05/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/05/2025
• 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