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

Catalog Number	ECR60D
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/03/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Date sent: 2/17/2026.D4: batch #unk.Additional information was requested, and the following was obtained: 1.Did the damage occur right out of the packaging or in the operative field? right out of the packaging.2.Was part of the packaging found to be damaged (tyvek, plastic/blister, packaging seal, etc.)? packaging seal.4.Could you please identify the packaging (shipping box, primary packaging, box, pouch seal, or the plastic bag)? pouch seal 5.Could you please clarify the type of damage found (broken, packaging was worn, bent, ragged, containing cut or slit, or appear ripped)? reload fell off.6.Was sterility compromised as a result of the packaging damage? -yes.A manufacturing record evaluation was performed for the finished device ecr60d with lot number 314c50; 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.
Event or Problem Description
It was reported that before an unknown procedure, it was observed that the packaging was damaged.Another device was used to complete the surgery.There were no adverse consequences to the patient.No additional information could be provided.
Additional Manufacturer Narrative
(b)(4).Date sent 3/3/2026 investigation summary the product was returned for evaluation.Visual inspection was conducted on the returned reload.Visual analysis of the returned sample determined that one ecr60d reload was received unfired, with no apparent damage, and with an opened package.Upon visual inspection, it was observed that the the flexible blister from the packaging was damaged (scratches).Sterility is not compromised.Due to the damages found on the flexible blister, a possible cause for these conditions is due to improper handling during transit or storage.Additionally, photos were provided and they showed an open package and what appear to be scratches on the flexible blister can be seen.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 lot number 314c50, and no non-conformances were identified.

• Brand Name: GOLD 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: 24369012
• Report Number: 3005075853-2026-01374
• Device Sequence Number: 18561708
• Product Code: GDW
• UDI-Device Identifier: 10705036011842
• UDI-Public: (01)10705036011842(10)314C50(17)280131
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/03/2026

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: ECR60D
• Device Lot Number: 314C50
• 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: 02/05/2026
• Supplement Date Received by Manufacturer: 02/23/2026
• Initial Report FDA Received Date: 02/17/2026
• Supplement Report FDA Received Date: 03/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/21/2023
• 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