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

Catalog Number	GST45W
Medical Device Problem Code	Separation Problem (4043)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/23/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an unknown laparoscopic urological procedure, the cartridge was used at the 1st firing, and the cartridge would not fit properly when trying to load the 2nd firing.After trying several times and still not being able to load, it was found that the cartridge pan (which had already been sent as a defect) was still left to the main body when checked the main body.The part remaining in the main body was removed with forceps and loaded.The doctor wanted to know why this was possible.The cartridge color was white.Another device was used to complete the case.There were no adverse consequences to the patient.No additional information provided.
Additional Manufacturer Narrative
(b)(4).Date sent: 1/7/2026.D4: batch #unk.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.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.
Additional Manufacturer Narrative
(b)(4).Date sent: 1/19/2026.D4: batch #813c60.Corrected data: d4 (udi, expiration date), h4.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 gst45w reload was returned fully fired with one tyvek, with the reload pan detached.In addition, 1 double driver out of position, making the reload non-functional.No functional test was performed due the condition of the reload.It is also possible that handling by the customer could dislodge the pan.Dislodgement as a result of the removal of the reload from the device is the most likely scenario.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 813c60, and no non-conformances were identified.

• Brand Name: GST WHITE 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: 23990041
• Report Number: 3005075853-2026-00193
• Device Sequence Number: 13308059
• Product Code: GDW
• UDI-Device Identifier: 10705036014928
• UDI-Public: (01)10705036014928(10)722C38(17)261230
• 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
• Report Date (Section B): 01/07/2026

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: GST45W
• Device Lot Number: 722C38
• 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: 12/23/2025
• Supplement Date Received by Manufacturer: 01/14/2026
• Initial Report FDA Received Date: 01/07/2026
• Supplement Report FDA Received Date: 01/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/26/2024
• 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