MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. BLUE RELOAD FOR ECHELON 60; STAPLE, IMPLANTABLE

Catalog Number	ECR60B
Medical Device Problem Code	Failure to Form Staple (2579)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a lap gastric sleeve procedure, it was observed that the reload did not lead to a b-formed shape as 4-5 pins looked open once firing completed.The surgeon did omentopexy for safety and completed the case.There was no bleeding or oozing reported.There was no patient consequence nor surgical delay reported.No additional information provided.
Additional Manufacturer Narrative
(b)(4).Date sent: 11/13/2025.B3: only event year known: 2025.The full udi is currently not available.Additional information was requested, and the following was obtained: malformed staples for sure.Patient discharged post-operative- all fine.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.A manufacturing record evaluation was performed for the finished device ecr60b with lot number 126c62; and no non-conformances 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.
Additional Manufacturer Narrative
(b)(4).Date sent: 12/01/2025 updated data: d4 (expiration date) corrected data: d4 (udi) investigation summary: this is an analysis of photos submitted for evaluation.During the visual analysis, the following was observed: the first and the second photo shows one tyvek related to a ecr60b with lot number 126c62 and with an expiration date of 2027-09-30, the third photo shows tissue with one staple line and the staples looks not formed as expected.Based on the photos the event described is confirmed, however no conclusion or root cause could be determined.Hands on device analysis may provide the additional evidence necessary to confirm the root cause of the reported event.Because the instrument was not returned our evaluation is limited.As part of ethicon endo-surgery quality process, all devices are manufactured, inspected, and released to approved specifications.

• Brand Name: BLUE RELOAD FOR ECHELON 60
• 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 00969 ; 3035526892
• MDR Report Key: 23542205
• Report Number: 3005075853-2025-08799
• Device Sequence Number: 9775477
• Product Code: GDW
• UDI-Device Identifier: 10705036001775
• UDI-Public: (01)10705036001775(10)126C62(17)270930
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K051002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/13/2025

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: ECR60B
• Device Lot Number: 126C62
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/01/2025
• Supplement Date Received by Manufacturer: 11/27/2025
• Initial Report FDA Received Date: 11/13/2025
• Supplement Report FDA Received Date: 12/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/11/2022
• 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