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

Catalog Number	EC3D60C
Medical Device Problem Code	Failure to Form Staple (2579)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Date sent: 3/11/2026 b3: only event year known: 2026 d4: batch # unk 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: please provide the product code and product lot for the device involved.Was it a partial cut? if so what was cut partially, washer or tissue? if yes/no, was there any issue with the cut is the current patient status known? was there any patient consequence or change in the post-operative care of the patient as a result of the event? 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 whipple procedure, they had fired the device 8-9 times and on the last firing, the staples looked like a v shape.The surgeon said they felt like the staple line was in tact, so no patient harm, but was still very unsettling.The surgeon believed there were about 6 that looked like the v shape at the distal end of the jaws.There was no patient consequence nor surgical delay reported.No additional information provided.
Additional Manufacturer Narrative
(b)(4).Date sent: 3/23/2026.D4: batch #unk.Additional information was requested, and the following was obtained: sales rep is unaware of any changes in the post-op care.There was no issue with the staple line or there being a worry about a leak.The surgeon felt fine with the staple line when closing the patient.The device upon which this medwatch is based has been received, however, the evaluation is not yet complete.Any further information derived from the evaluation will be submitted in a supplemental 3500a form.
Additional Manufacturer Narrative
(b)(4).Date sent: 4/20/2026.D4: batch #unk.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 no apparent damage and with no reload present.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.The event described could not be confirmed as the device performed without any difficulties noted.No malformed staples were observed.A review of the event log showed that the device was fired 7 times clinically; no issues were found in the log.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 a9968z, and no non-conformances were identified.

• Brand Name: ETHICON 4000 STAPLER STRAIGHT 60 COMPACT
• Common Device Name: STAPLER, SURGICAL
• 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: 24574452
• Report Number: 3005075853-2026-01941
• Device Sequence Number: 9234046
• Product Code: GAG
• UDI-Device Identifier: 10705036043539
• UDI-Public: (01)10705036043539(10)A9968Z(17)281031
• Combination Product (Y/N): N
• Initial Reporter State: AR
• 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,Followup
• Report Date (Section B): 03/11/2026

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: A9968Z
• 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: 02/23/2026
• Supplement Date Received by Manufacturer: 03/11/2026; 04/17/2026
• Initial Report FDA Received Date: 03/11/2026
• Supplement Report FDA Received Date: 03/23/2026; 04/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/05/2025
• 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