MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ETHICON 3D RELOAD 60MM BLUE; STAPLE, IMPLANTABLE

Catalog Number	ER60B
Medical Device Problem Code	Failure to Form Staple (2579)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/25/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4) date sent: d4: batch #unk.Additional information was requested, and the following was obtained: can you please describe in detail how the device was cleaned in between firings? first firing was the device fired across another staple line? no can you please send photos for review if available? staple was sent in was buttressing material used? if so, what kind? no 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.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 roux-en-y procedure, the surgeon fired the staple load across the small intestine, and majority of the staples were fired, however this one was essentially fired vertically in a straight line looking like a wire which looks very malformed where it could have perforated an organ or vessel.That staple load fired appropriately outside from this staple line was hemostatic and satisfactory.But the concern lies with the malformed shapes of the staples.There was no patient consequence nor surgical delay reported.No additional information provided.
Additional Manufacturer Narrative
(b)(4).Date sent: 4/23/2026.D4: batch #875d07.Updated data: h6 (type of investigation).A manufacturing record evaluation was performed for the finished device batch number of 875d07 / 12er60b , and no non-conformances were identified.

• Brand Name: ETHICON 3D RELOAD 60MM BLUE
• 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: 24639365
• Report Number: 3005075853-2026-02100
• Device Sequence Number: 10008882
• Product Code: GDW
• UDI-Device Identifier: 10705036040811
• UDI-Public: (01)10705036040811(10)875D07(17)281231
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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,Followup
• Report Date (Section B): 03/19/2026

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: ER60B
• Device Lot Number: 875D07
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/25/2026
• Supplement Date Received by Manufacturer: 04/22/2026
• Initial Report FDA Received Date: 03/19/2026
• Supplement Report FDA Received Date: 04/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/19/2026
• 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