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

Catalog Number	GEN11
Medical Device Problem Code	Complete Loss of Power (4015)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/04/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during an unknown procedure the generator is showing problem only after very few cases.It's restarting again and again which is causing the surgeon to be unable to perform surgery.
Additional Manufacturer Narrative
(b)(4).Date sent: 9/25/2024.D4 batch #: unknown.Attempts are being made to obtain the following information.To date, no response has been provided.If further details are received at a later date, a supplemental medwatch will be sent: what was the planned surgical procedure? what generator alert screens were seen? what is meant by "restarting again and again"? does the facility use a power conditioner? was the surgery cancelled as a result of the difficulties with the generator? were there any patient consequences? did the user consider using other cutting and coagulating devices prior to cancelling the procedure (if applicable)? what is the generator¿s return status? 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.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: 10/2/2024.Additional information was requested and the following was obtained: q.What was the planned surgical procedure? ans.Total laparoscopic hysterectomy.Q.What generator alert screens were seen? ans.It was not showing any alert.Q.What is meant by "restarting again and again"? ans.They are saying generator was switching off and restart after some time.Q.Does the facility use a power conditioner? ans.Unknown.Q.Was the surgery cancelled as a result of the difficulties with the generator? ans.No, some other device used.Q.Were there any patient consequences? ans.No patient consequences.Q.Did the user consider using other cutting and coagulating devices prior to cancelling the procedure (if applicable)? ans.Na.Upon review of the information provided, it was concluded that this event does not meet the fda defined criteria for a reportable event and is being considered not reportable.

• Brand Name: EES GENERATOR
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• 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: 20300962
• Report Number: 3005075853-2024-07232
• Device Sequence Number: 7588838
• Product Code: GEI
• UDI-Device Identifier: 20705036013959
• UDI-Public: (01)20705036013959
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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: Foreign,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: GEN11
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/05/2024
• Supplement Date Received by Manufacturer: 09/25/2024
• Initial Report FDA Received Date: 09/25/2024
• Supplement Report FDA Received Date: 10/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown