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

Catalog Number	GST45T
Medical Device Problem Codes	Failure to Fire (2610); Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/23/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Date sent: 01/07/2025.D4: batch#: unk.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent: did the device lock-out (no staples deployed and no cut line started)? or, did the device start to deploy staples and cut but could not be completed (partially fire)? or, did the device fully fire and stop during the automatic knife return? was there any difficulty opening the device? if yes, how was the device removed from the patient? if yes, did the jaws eventually open? could you please specify how the trocar was damaged, was the sleeve damaged? was the housing damaged? was there any insufflation issue? was there any seal damaged? any visible broken part? 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.A manufacturing record evaluation was performed for the finished device gst45t with lot number: 349c63; and no non-conformance's were identified.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 a lobectomy procedure, it was observed that in the course of a procedure using the psee60a, an error occurred in the process of firing.When surgeon pulled back the safety lock and fired the trigger, the blade was suddenly stopped in the middle of cartridge.It occurred two more times.As an emergency measure, the surgeon backed off the blade and detached it from the tissue.It was further reported that the trocar had been bent when it was inserted into the body.There were no adverse consequences to the patient nor surgical delay reported.Additional information requested.
Additional Manufacturer Narrative
(b)(4).Date sent: 05/06/2025.An analysis of the product could not be performed since a physical sample was not received for evaluation.However, if the product is received at a later date, the investigation will be updated as applicable.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.
Additional Manufacturer Narrative
(b)(4).Date sent: 07/28/2025.D4: batch # 254c63.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 determined that one gst45t reload was received unfired, with no apparent damage, and with an opened package.The device was not returned for analysis.The returned reload was 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 staples met the staple release criteria.No conclusion could be reached on the cause of difficult to open since no device was returned for analysis.The event described could not be confirmed as the reload performed without any difficulties noted.Although the cause of the reported incident could not be determined, proper use of the endo linear cutters - echelon 45mm - powered+ is important to ensure functionality.As part of ethicon endo surgery¿s quality process, all devices are manufactured, inspected, and released to approved specifications.Device history review: a manufacturing record evaluation was performed for the finished device batch number 254c63, and no non-conformances were identified.

• Brand Name: GST BLACK 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: kate karberg ; 475 calle c; guaynabo 00969 ; 3035526892
• MDR Report Key: 21095291
• Report Number: 3005075853-2025-00162
• Device Sequence Number: 9161554
• Product Code: GDW
• UDI-Device Identifier: 10705036014911
• UDI-Public: (01)10705036014911(10)349C63(17)251231
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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,Followup
• Report Date (Section B): 01/07/2025

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 Expiration Date: 12/31/2025
• Device Catalogue Number: GST45T
• Device Lot Number: 349C63
• 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: 12/22/2024
• Supplement Date Received by Manufacturer: 04/29/2025; 07/08/2025
• Initial Report FDA Received Date: 01/07/2025
• Supplement Report FDA Received Date: 05/06/2025; 07/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/20/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: PSEE60A.
• Patient Sex: Unknown