MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. GST GREEN RELOAD 45MM 6 ROW; STAPLE, IMPLANTABLE

Catalog Number	GST45G
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4) date sent: 1/7/2026 d4: batch #unk d4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.D4: udi: the expiration date is currently not available.Therefore, the full udi is currently not available.H4: the device manufacture date is currently not available.Additional information was requested, and the following was obtained: all broken pieces have been retrieved.There is no risk of remaining inside the body.No lot or batch number was provided; therefore, a device history could not be done.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 unknown procedure, part of the green plastic part of the gst cartridge was chipped after firing.The device was fired on a previous staple line.The fragments were collected and discarded to complete the case.The device was used for interlobar formation.There was no effect on the patient.The cartridge color was green.Another device was used to complete the case.There were no adverse consequences to the patient.No additional information was provided.
Additional Manufacturer Narrative
(b)(4).Date sent 2/19/2026.The device upon which this medwatch is based has been received, however, the evaluation is not yet complete.Any further information derived from the evaluation will be submitted in a supplemental 3500a form.
Additional Manufacturer Narrative
(b)(4).Date sent 2/24/2026.Investigation summary: visual analysis of the returned sample determined that one gst45g reload was not received for analysis.It was received only one plastic bag with a little yellow piece of foreign matter.Since no reload was returned for analysis, no visual inspection could be performed to evaluate the incident reported.It could not be determined what may have caused the reported event.The event could not be confirmed as no reload was returned for analysis.The reported complaint could not be confirmed.This report is not intended to deny that you experienced a problem with the reload.There may have been other circumstances or issues that occurred during the use of the reload that we were unable to duplicate during our laboratory analysis.As part of ethicon endo surgery¿s quality process all devices are manufactured, inspected, and released to approved specifications.An evaluation of the manufacturing record could not be performed as the required product identification number was not provided to complete the evaluation.

• Brand Name: GST GREEN RELOAD 45MM 6 ROW
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer Contact: orla o'mahony ; 475 calle c; guaynabo 00969 ; 3035526892
• MDR Report Key: 23994059
• Report Number: 3005075853-2026-00224
• Device Sequence Number: 13317687
• Product Code: GDW
• UDI-Device Identifier: 10705036014904
• UDI-Public: 10705036014904
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K163454
• 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,Followup,Followup
• Report Date (Section B): 02/24/2026

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: GST45G
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/24/2025
• Supplement Date Received by Manufacturer: 02/02/2026; 02/23/2026
• Initial Report FDA Received Date: 01/07/2026
• Supplement Report FDA Received Date: 02/19/2026; 02/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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