MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ETHICON 4000 STAPLER STRAIGHT 60 COMPACT; STAPLE, IMPLANTABLE

Catalog Number	EC3D60C
Medical Device Problem Code	Failure to Fire (2610)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Date sent: 1/8/2026.D4: batch #a98w62.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 ec3d60c device was returned with a er60w reload present.The reload was received partially fired (b)(6).After further evaluation, a review of the manufacturing ct data for the returned reload shows that sled was in the home position and the staples were below the deck of the reload at the end of manufacturing assembly.In addition, visual inspection of the device showed that there were some formed staples in the jaws and that there was a dent in the fin of the nozzle.The device was tested for functionality in the straight position with a test reload 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.However, the knife was noted to have nicks.No conclusion could be reached as to what may have caused the nozzle to be damaged.It is possible that while loading the reload, the reload was pushed farther back than the reload alignment slot resulting in the knife pushing the one-piece sled forward and locking the reload.Please note that the retainer must remain in place within the reload until it is fully installed in the device.One possible cause for this type of damage to the knife is when the device is fired over an already existing staple line, hard object, or thicker tissue than indicated.Repeatedly firing across existing staple lines can also reduce the ability to cut cleanly.To mitigate the potential for staples getting into the reload and interfering with the knife path during device firing, prior to reloading the device, rinse the anvil and reload jaw in sterile solution and then wipe the anvil and reload jaw to clean any formed but unused staples from the device.Additionally, proper care should be taken when placing the device on the tissue to be stapled, to ensure that no hard obstruction such as a clip is included with the tissue inside the jaws.A review of the device event log shows that the device was fired 8 times in a clinical setting after both the inline and fgqa firing in manufacturing.The device was fired into lockout between the 4th and 5th full clinical firing sequences.The firing trigger was pulled multiple times and then an articulation button was pressed while the jaws were still closed after the lockout was encountered.Additionally, clinical firing 6 and 8 have high force to fire, indicating that the device was fired on thick tissue or over a hard object.Additionally, photo was provided and they showed a shipping box.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 a98w62, and no non-conformances related to the reported complaint condition 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 whipple procedure, it was observed that the device did not activate when the surgeon attempted to fire it.The reload was then replaced, and the stapler functioned properly.There was no patient consequence nor surgical delay reported.No additional information provided.

• Brand Name: ETHICON 4000 STAPLER STRAIGHT 60 COMPACT
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): 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: 24010393
• Report Number: 3005075853-2026-00280
• Device Sequence Number: 11983975
• Product Code: GDW
• UDI-Device Identifier: 10705036043539
• UDI-Public: (01)10705036043539(10)A98W62(17)280930
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/08/2026

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: EC3D60C
• Device Lot Number: A98W62
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/07/2026
• Initial Report FDA Received Date: 01/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/20/2025
• 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