MAUDE Adverse Event Report: Ethicon Endo-Surgery, LLC. ENDOPATH; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number	5DCS
Medical Device Problem Codes	Arcing (2583); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/06/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Date sent 8/10/2026.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 8/17/2026.D4 batch # a98z0f.Corrected data d4: udi# investigation summary.The product was returned for evaluation.Visual inspection and functional testing were conducted on the returned device.Visual analysis of the returned sample determined that the 5dcs device was returned with no apparent damage.In addition, the tyvek was returned along with the instrument.To evaluate the reported cutting issue, the device was tested for functionality and successfully cut the test media as intended, with no anomalies observed during testing.The device was found to be fully functional and operating in accordance with manufacturing specifications.As part of ees quality process all devices are manufactured, inspected, and released to approved specifications.The event described could not be confirmed as the device was returned without detectable damage.Although no product defect was identified, there may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the laboratory analysis.A manufacturing record evaluation was performed for the finished device batch a98z0f number, and no non-conformances were identified.

• Brand Name: ENDOPATH
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): Ethicon Endo-Surgery, LLC.; 475 calle c; guaynabo 00969 ; PR 00969
• Manufacturer (Section G): Ethicon Endo-Surgery, LLC.; 475 calle c; guaynabo 00969 ; PR 00969
• Manufacturer Contact: orla o'mahony ; 475 calle c; guaynabo ; PR ; +1(303)552-6892
• MDR Report Key: 50012843
• Report Number: 3005075853-2026-05906
• Device Sequence Number: 21477396
• Product Code: GEI
• UDI-Device Identifier: 10705036000785
• UDI-Public: (01)10705036000785(17)300930(10)807D95
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K984240
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/17/2026

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: 5DCS
• Device Lot Number: 807D95
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/28/2026
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 07/07/2026
• Supplement Date Received by Manufacturer: 07/28/2026; 07/28/2026
• Initial Report FDA Received Date: 07/27/2026
• Supplement Report FDA Received Date: 08/10/2026; 08/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/09/2025
• 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