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

Catalog Number	GST45G
Medical Device Problem Code	Failure to Fire (2610)
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: 10/27/2025 b3: only event year known: 2025 d4: batch #unk additional information was requested, and the following was obtained: did the device deliver any staples? >> yes.If yes, were the staples formed properly? >>the staples were properly formed.If yes, was the staple line complete? >>only half of the staples were fired, resulting in a partial staple line.Did the device cut? >>yes if yes, was the cut line complete? >>the cut line was complete for the half that was fired.If yes, was there any issue with the cut line such as jagged, dull knife, irregular, etc? >>no issues observed.Was there any difficulty opening the device? >>no difficulty opening the device; it was able to open normally after using the reverse lever.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.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 stapler cartridge got stuck halfway and could not advance further.There was no patient consequence nor surgical delay reported.No additional information provided.

• Brand Name: GST GREEN 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: 23395488
• Report Number: 3005075853-2025-08291
• Device Sequence Number: 15997232
• Product Code: GDW
• UDI-Device Identifier: 10705036014904
• UDI-Public: 10705036014904
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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): 10/27/2025

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: GST45G
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/12/2025
• Initial Report FDA Received Date: 10/27/2025
• 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