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

Catalog Number	GST45D
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: 1/29/2026.D4: batch #unk.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.An analysis of the product could not be performed since a physical sample was not received for evaluation.An evaluation of the manufacturing record could not be performed as the required product identification number was not provided to complete the evaluation.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Based on the information available, there is no indication that a design or manufacturing issue has caused the reported complaint condition; therefore, it has been determined that no corrective and preventive action is required at this time.However, if the product is received at a later date, the investigation will be updated as applicable.
Event or Problem Description
It was reported that during an unknown procedure, part of the gold 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.

• 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 ; * 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer Contact: orla o'mahony ; 475 calle c; guaynabo 00969 ; * 00969 ; 3035526892
• MDR Report Key: 24215379
• Report Number: 3005075853-2026-00894
• Device Sequence Number: 18164108
• Product Code: GDW
• UDI-Device Identifier: 10705036014898
• UDI-Public: 10705036014898
• 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
• Report Date (Section B): 01/29/2026

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
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/21/2026
• Initial Report FDA Received Date: 01/29/2026
• 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