MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. EES GENERATOR; INSTRUMENT, ULTRASONIC SURGIICAL

Catalog Number	GEN11
Medical Device Problem Codes	Failure to Read Input Signal (1581); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an unknown procedure the unit emits a burning smell and fails the electrical safety test.
Additional Manufacturer Narrative
(b)(4).Date of event: event year only reported: 2023.Batch #: unknown.The lot/batch was not provided; therefore, the manufacturing records evaluation could not be performed.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: 2/15/2023.Investigation summary: per service manual operational and diagnostic analysis confirmed the burning smell and the electrical safety failure.The epac top, epac middle, epac bottom and cable assembly, enclosure / heat sink fan to main board were replaced as identified in the investigation to address the issues.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 repair and testing of the unit was completed.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.

• Brand Name: EES GENERATOR
• Common Device Name: INSTRUMENT, ULTRASONIC SURGIICAL
• 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: kate karberg ; 475 calle c; guaynabo ; 3035526892
• MDR Report Key: 16334529
• Report Number: 3005075853-2023-00882
• Device Sequence Number: 12367195
• Product Code: GEI
• UDI-Device Identifier: 10705036013952
• UDI-Public: 10705036013952
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/09/2023

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: 01/31/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/24/2023
• Supplement Date Received by Manufacturer: 02/09/2023
• Initial Report FDA Received Date: 02/09/2023
• Supplement Report FDA Received Date: 02/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown