MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ECHLEON; OXC

Catalog Number	ECH60R
Medical Device Problem Code	Ambient Temperature Problem (2878)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/19/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during incoming inspection at the distributor: (b)(4), they found the temperature indicator on the outer carton had turned red, and among the six inner boxes, one box had also turned red.No additional information provided.
Additional Manufacturer Narrative
(b)(4) date sent: 04/03/2026.D4: batch #: unknown.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: 4/15/2026.Updated data: h6 (type of investigation): a manufacturing record evaluation was performed for the finished device ech60r; xdcbtgs0 number, and no non-conformances were identified.

• Brand Name: ECHLEON
• 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: 24780290
• Report Number: 3005075853-2026-02496
• Device Sequence Number: 17675806
• Product Code: OXC
• UDI-Device Identifier: 10705036023296
• UDI-Public: (01)10705036023296(10)XDCBTGS0(17)270331
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup

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
• Device Lot Number: XDCBTGS0
• 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: 03/23/2026
• Supplement Date Received by Manufacturer: 04/12/2026; 06/19/2026
• Initial Report FDA Received Date: 04/03/2026
• Supplement Report FDA Received Date: 04/15/2026; 06/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/09/2025
• 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