MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. 55 MM NTLC SELECTABLE RELOAD; STAPLE, IMPLANTABLE

Catalog Number	SR55
Medical Device Problem Code	Failure to Fire (2610)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4) date sent 4/21/2025 d4 batch #127d34.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 sr55 reload was received with the retainer placed and no apparent damaged.In addition, an opened package was received along with the device.The reload had the proximal 1 driver up and the remaining drivers down with staples present and a swing tab in the unlocked position.Also, the reload was received with the knife not completely within doghouse.It is possible that the knife exposed noted on the reload is consist with the firing knob was not returned completely prior to opening the device causing that the knife not returned completely to its home position.The reload was tested for functionality with a test device and fired without any difficulties.The staple line and cut line were complete, and the staples meet the staple form release criteria.The swing tab in unlocked position is consistent with an improper loading technique.Please reference the instruction for use for more information.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 127d34, and no non-conformances were identified.The lot#140d30 history records were reviewed and certified by external manufacturing that the manufacturing criteria were met prior to the release of the equipment.The certificate records are accessible through external manufacturing.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: 1.Could you please clarify if there were any patient consequences? 2.Could you please clarify if there was any change in the post-operative care of the patient as a result of the event? 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 gastrectomy the device did not fire.

• Brand Name: 55 MM NTLC SELECTABLE RELOAD
• 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 ; * ; 3035526892
• MDR Report Key: 21872236
• Report Number: 3005075853-2025-02799
• Device Sequence Number: 12692527
• Product Code: GDW
• UDI-Device Identifier: 10705036002826
• UDI-Public: (01)10705036002826(17)290531(10)140D30
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K092577
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/21/2025

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: SR55
• Device Lot Number: 140D30
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/02/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/09/2025
• Initial Report FDA Received Date: 04/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/07/2024
• 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