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

Catalog Number	ER60G
Medical Device Problem Code	Failure to Form Staple (2579)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/18/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a robotic pancreatoduodenectomy, the stomach was transected using two green cartridge firings.Malformed staples were observed frequently on the first firing.It was difficult to determine whether there were malformed staples on the second firing because there were only a few staples remaining.The product was used on the stomach.The cartridge color was green.There were no adverse consequences to the patient nor surgical delay reported.No additional information provided.
Additional Manufacturer Narrative
(b)(4).Date sent: 6/02/2026.D4: batch #unknown.D4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.D4: udi: the expiration date is currently not available.Therefore, the full udi is currently not available.H4: the device manufacture date is currently not available.Additional information was requested, and the following was obtained: no usual sensation or abnormality was noted during use of the device.More staples than usual appeared not to be properly formed into a b-shape.Any pictures or video available? no.What is meant by there are only a few staples remaining on the 2nd firing? 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.No lot or batch number was provided; therefore, a device history could not be done.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: ETHICON
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer Contact: orla o'mahony ; 475 calle c; guaynabo 00969 ; 3035526892
• MDR Report Key: 25363273
• Report Number: 3005075853-2026-04200
• Device Sequence Number: 16122157
• Product Code: GDW
• UDI-Device Identifier: 10705036040798
• UDI-Public: (01)10705036040798(17)281130(10)IZQ1205410
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K241630
• 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
• Report Date (Section B): 06/02/2026

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: ER60G
• Device Lot Number: IZQ1205410
• 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: 05/17/2026
• Supplement Date Received by Manufacturer: 06/10/2026
• Initial Report FDA Received Date: 06/02/2026
• Supplement Report FDA Received Date: 06/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/11/2025
• 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