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

Catalog Number	SR75
Medical Device Problem Code	Failure to Fire (2610)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a laparotomy for small-bowel resection in the setting of mesenteric ischemia.While using a violet 60 mm endogia stapler (lot number unknown) to resect the last 20 cm of small intestine, the stapler cartridges failed to fire on three occasions.This caused a delay to the surgical procedure and posed a risk of hemorrhage.A different lot was used successfully.
Additional Manufacturer Narrative
B)(4).Date sent: 6/8/2026 d4: batch # 807d17.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 sample revealed that the sr75 reload (c) was received with no apparent damage.The reload was received fully loaded with staples and the swing tab was found to be in the unlocked position.The reload was tested for functionality with a test device and it fired, cut and formed all the staples as intended.The staple line and cut line were complete, and the staples met the staple form release criteria.However, one staple was found missing on the distal end.The event described could not be confirmed as the reload performed without any difficulties noted.It is possible that improper handling of the reload caused the staples to fall out; the proper handling instructions should be used when removing and reloading cartridges into the device.Please reference the instructions for use for more information.It should be noted that 100% inspection is performed by means of an automated vision system to ensure staples presence.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 807d17, and no non-conformances were identified.Additional information was requested and the following was obtained: is the current patient status known? stable condition was there any patient consequence or change in the post-operative care of the patient as a result of the event? (extended hospital stay, readmission, re-operation, etc.) no.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: 25436960
• Report Number: 3005075853-2026-04382
• Device Sequence Number: 16042193
• Product Code: GDW
• UDI-Device Identifier: 10705036002833
• UDI-Public: (01)10705036002833(17)301031(10)821D39
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 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: 821D39
• 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): Yes
• Date Device Manufactured: 11/10/2025
• 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