MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. N/A; STAPLE, IMPLANTABLE

Catalog Number	SR75
Medical Device Problem Code	Structural Problem (2506)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an unk procedure, yellow anvil driver was already pushed down therefore could not use on patient.
Additional Manufacturer Narrative
(b)(4).Date sent: 6/8/2026 b3: exact event date unk, entered 1/1/2026 as only the year was provided.D4: batch # 382d70 investigation summary the product was returned to ees for evaluation.Visual inspection and functional testing were conducted on the returned device.Visual analysis of the returned sr75 reload (a) determined that it was received with no apparent damage, the swing tab was in the locked position, and 5 drivers were up on the proximal end without staples.The reload swing tab was reset in order to fire the cartridge, and the reload was tested for functionality with a test device and fired without any difficulties.The staple line was complete, and the staples met the staple form release criteria.However, after fired, 3 staples were missing on the distal end.The event reported was confirmed and is related to improper use of the device.It is possible that improper handling of the reload caused the staples to fall out; proper handling instructions should be used when removing and reloading cartridges into the device.The cartridge reload is designed to lock out as a safety feature if any staples have been fired from the cartridge reload, and failure to complete the stroke may result in an incomplete staple line.Please reference the instruction for use for more information.As part of ees 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 382d70, and no non-conformances were identified.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 damage occur right out of the packaging or in the operative field? 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.

• Brand Name: N/A
• 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: 25436397
• Report Number: 3005075853-2026-04380
• Device Sequence Number: 10335730
• Product Code: GDW
• UDI-Device Identifier: 10705036002833
• UDI-Public: (01)10705036002833(17)291231(10)408D54
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/08/2026

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: SR75
• Device Lot Number: 408D54
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/16/2026
• Initial Report FDA Received Date: 06/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/09/2025
• 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