MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. EES GENERATOR; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number	GEN11
Medical Device Problem Code	Failure to Read Input Signal (1581)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4) date sent: 11/17/2025 d4 batch #: unknown.Additional information was obtained: this was a demo unit returned from a prof ed event that failed incoming electrical safety.There is no patient consequence as it is a not-for-human device.Investigation summary per service manual operational and diagnostic analysis confirmed the reported failed electrical safety.The foot connector and enclosure bottom deco assembly were replaced as identified in the investigation to address the issue.Additionally, the patent label and magnetic rep label were replaced.These replaced labels were unrelated to the reported issue.The repair and testing of the unit was completed per the service manual, bringing the unit back to full functionality.The unit passed all functional tests and is fully operational.The device history records were reviewed and certed by external manufacturing that the manufacturing criteria were met prior to the release of the equipment.The certificate records are accessible through external manufacturing.
Event or Problem Description
It was reported by service and repair that, special use demo request for lab ending 9/19/2025 10/28/2025 - unit failed electrical safety.Converted from pm to cm.

• Brand Name: EES GENERATOR
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer Contact: orla o'mahony ; 475 calle c; guaynabo ; * ; 3035526892
• MDR Report Key: 23569948
• Report Number: 3005075853-2025-08863
• Device Sequence Number: 13228674
• Product Code: GEI
• UDI-Device Identifier: 20705036013959
• UDI-Public: (01)20705036013959
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K200841
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/17/2025

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: GEN11
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/29/2025
• Initial Report FDA Received Date: 11/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown