MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. GST BLACK RELOAD 60MM 6 ROW; STAPLE, IMPLANTABLE

Catalog Number	GST60T
Medical Device Problem Code	Failure to Form Staple (2579)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a laparoscopic right lower lobectomy procedure, the device was used during a bronchial resection at the 2nd firing, but one leg of the staple at the distal side did not form as intended.The leg of unformed staple was cut with scissors, and additional suture was performed to complete the case.The cartridge color was black.There were no adverse consequences to the patient.No additional information was provided.
Additional Manufacturer Narrative
(b)(4).Date sent: 12/11/2025 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: the lot/batch number provided bp7752 has been revised for the product code gst60t, however, our system does not identify the lot/batch number for this product code.Could you please provide the correct lot number? => unk.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.

• Brand Name: GST BLACK RELOAD 60MM 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: 23782334
• Report Number: 3005075853-2025-09413
• Device Sequence Number: 15809707
• Product Code: GDW
• UDI-Device Identifier: 10705036014720
• UDI-Public: 10705036014720
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K110385
• 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): 12/11/2025

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: GST60T
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/26/2025
• Initial Report FDA Received Date: 12/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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