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

Catalog Number	GST45D
Medical Device Problem Codes	Material Integrity Problem (2978); Separation Problem (4043)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Date sent: 2/5/2026.B3: unknown.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: was the damage of the device discovered before opening the packaging? or, was the damage discovered after opening and manipulating the device? after opening.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.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, it was observed that the cartridge and the metal part were not properly attached when opened the cartridge.Also, one side of the tip was bent.Another cartridge was used to handle the situation.Even after asking the distribution agency and the operating nurse, the operation date and the surgeon were unknown.The device was not used for the patient.The cartridge color was gold.Additional suture was performed to complete the case.There were no adverse consequences to the patient.No additional information provided.
Additional Manufacturer Narrative
(b)(4).Date sent 2/17/2026.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: 2/23/2026.D4: batch #900c39.Updated data: d4 (lot number, expiration date), h4.Corrected data: d4 (udi).Investigation summary: the product was returned for evaluation.Visual inspection and functional testing were conducted on the returned device.Visual analysis of the returned sample revealed that the gst45d reload was returned unfired with one tyvek, with the reload pan bend and partially dislodged from the left proximal side.In addition, 1 double driver missing, making the reload non-functional.No functional test was performed due the condition of the reload.No conclusion could be reached on what may have caused the reload pan to dislodge.As part of our quality process, the manufacturing records of this batch number were reviewed, and the manufacturing standards were met prior to the release of this batch.As part of ethicon endo surgery¿s quality process, all devices are manufactured, inspected, and released to approved specifications.A manufacturing record evaluation was performed for the finished device batch number 900c39, and no non-conformances were identified.

• Brand Name: GST GOLD 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: 24268352
• Report Number: 3005075853-2026-01049
• Device Sequence Number: 10658459
• Product Code: GDW
• UDI-Device Identifier: 10705036014898
• UDI-Public: (01)10705036014898(10)900C39(17)270430
• 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): 02/17/2026

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: GST45D
• Device Lot Number: 900C39
• 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: 01/20/2026
• Supplement Date Received by Manufacturer: 02/09/2026; 02/20/2026
• Initial Report FDA Received Date: 02/05/2026
• Supplement Report FDA Received Date: 02/17/2026; 02/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/15/2024
• 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