MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ECHELON 60MM REINFORCEMENT; OXC

Catalog Number	ECH60R
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an unknown procedure it was observed that the staple line reinforcement on the anvil side was peeled off.The cartridge color was blue.Another device was used to complete the case.There were no adverse consequences to the patient.No further information is available.
Additional Manufacturer Narrative
(b)(4) date sent: 1/5/2026 d4: batch #unk d4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.D4: udi: the expiration date is currently not available.Therefore, the full udi is currently not available.H4: the device manufacture date is currently not available.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.No lot or batch number was provided; therefore, a device history could not be done.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 1/29/2026.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 2/3/2026.Investigation summary: the product was returned for evaluation.Visual inspection was conducted on the returned applicator.Visual analysis of the returned sample determined that one gst60b reload was received unfired, with no apparent damage, and with a buttressing loaded on the reload deck.The buttress was received with visible degradation/flaking due to previous exposure, the time out of foil packaging, and the decontamination process, the integrity of the absorbable materials could not be assessed and therefore no further testing could be conducted.No conclusion could be reached on the cause of the reported event.As part of our quality process, the manufacturing records of this lot number were reviewed, and the manufacturing standards were met prior to the release of this lot.As part of ethicon endo surgery¿s quality process, all devices are manufactured, inspected, and released to approved specifications.An evaluation of the manufacturing record could not be performed as the required product identification number was not provided to complete the evaluation.

• Brand Name: ECHELON 60MM REINFORCEMENT
• Common Device Name: OXC
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer (Section G): ETHICON ENDO SURGERY
• Manufacturer Contact: orla o'mahony ; 475 calle c; guaynabo 00969 ; 3035526892
• MDR Report Key: 23960669
• Report Number: 3005075853-2026-00086
• Device Sequence Number: 9473843
• Product Code: OXC
• UDI-Device Identifier: 10705036023296
• UDI-Public: 10705036023296
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K190937
• 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): 02/03/2026

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: ECH60R
• 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: 12/17/2025
• Supplement Date Received by Manufacturer: 01/20/2026; 02/02/2026
• Initial Report FDA Received Date: 01/05/2026
• Supplement Report FDA Received Date: 01/29/2026; 02/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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