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

Catalog Number	GST60T
Medical Device Problem Codes	Difficult to Open or Close (2921); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Date sent: 12/23/2025.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.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 jaw on the device could not be opened after firing.There was no patient consequence nor surgical delay reported.No additional information provided.
Additional Manufacturer Narrative
(b)(4).Date sent 2/3/2026.Investigation summary: the product was returned for evaluation.Visual inspection and functional testing were conducted on the returned reload.Visual analysis of the returned sample determined that one gst60t reload was received partially fired.The returned reload was reset and loaded into a test device.The returned reload was tested for functionality with a test device in the straight position and achieved its complete firing sequence without any difficulties.The staple line and cut line were complete and the remaining staples meet the staple form release criteria.It is possible that the combination of tissue and/or buttressing material compressed between the device jaws may have been beyond indicated thickness.This may have prevented the top of the knife blade assembly from entering into the anvil.Please reference the instruction for use for more information.No conclusion could be reach on the cause of the reported event of would not open and would not reverse button force since the device was not received.As part of ethicon endo surgery¿s quality process, all devices are manufactured, inspected, and released to approved specifications.Manufacturing record evaluation is not required as the reported event is not associated with the manufacturing process and/or the potential cause of the defect cannot be associated to manufacturing.
Additional Manufacturer Narrative
(b)(4).Date sent: 1/15/2026.D4: batch #unk.Corrected data: h6 (medical device problem code).Additional information was requested, and the following was obtained: what troubleshooting steps were attempted to open the device (e.G.Squeezing the closing trigger while simultaneously depressing the anvil release button, knife reverse switch, manual override)? anvil release button.Did the jaws eventually open? no.Place the reload, close the jaw and inserted through trocar into the chest, then the jaws was unable to open.Was the device locked on tissue with the jaws closed? no.If yes, how was the device removed? no.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.

• 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
• 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: 23881455
• Report Number: 3005075853-2025-09760
• Device Sequence Number: 20026673
• Product Code: GDW
• UDI-Device Identifier: 10705036014720
• UDI-Public: 10705036014720
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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,Followup,Followup
• Report Date (Section B): 02/03/2026

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: GST60T
• 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: 12/08/2025
• Supplement Date Received by Manufacturer: 01/06/2026; 02/02/2026
• Initial Report FDA Received Date: 12/23/2025
• Supplement Report FDA Received Date: 01/15/2026; 02/03/2026
• 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