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

Catalog Number	ECH60L
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/06/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Date sent: 5/13/2026.D4 batch # unk.An analysis of the product could not be performed since a physical sample was not received for evaluation.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.However, if the product is received at a later date, the investigation will be updated as applicable.The manufacturing records were reviewed and the manufacturing/packaging criteria were met prior to the release of this lot.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: 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? 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
During a surgical procedure for bph (benign prostatic hyperplasia), when opening the echelon 3000/340 stapler with a 60mm jaw, it was identified that, despite the outer packaging being intact and properly sealed, the plastic sleeve covering the jaw displayed droplets of moisture, resembling condensation/vapor.The finding was observed at the moment the sterile product was removed from the transparent packaging and handed to the scrub nurse.The condition was seen by the nursing team and by the operating surgeon.Given the inability to guarantee the sterility of the product, the material was initially segregated and a replacement was requested from the pharmacy.At the pharmacy, all available units of the echelon 3000/340 with a 60mm jaw belonged to the same lot.Upon opening the primary packaging for inspection, it was noted that all units showed the same moisture-droplet appearance in the jaw area, totaling 6 units that are segregated in the surgical center pharmacy and 1 unit that was opened and discarded.As a mitigation attempt, an echelon 340/440 with a 60mm jaw was requested and, upon opening that unit, a droplet was also observed, though in a minimal, almost imperceptible amount.Due to the already prolonged surgical time (approximately 30 minutes of waiting), the surgeon evaluated the material and opted to use it despite the observed condition.Was there a significant delay? yes how long was the delay (minutes)? 20-30 minutes.

• Brand Name: ECHELON
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer Contact: orla o'mahony ; 475 calle c; guaynabo ; 3035526892
• MDR Report Key: 25161609
• Report Number: 3005075853-2026-03598
• Device Sequence Number: 8661048
• Product Code: GAG
• UDI-Device Identifier: 10705036034988
• UDI-Public: (01)10705036034988(17)281031(10)A99697
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K213633
• 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,Followup
• Report Date (Section B): 06/16/2026

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: ECH60L
• Device Lot Number: A99697
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/06/2026
• Supplement Date Received by Manufacturer: 05/18/2026; 06/15/2026
• Initial Report FDA Received Date: 05/13/2026
• Supplement Report FDA Received Date: 05/28/2026; 06/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/25/2025
• 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