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

Catalog Number	GEN11
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	01/01/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Date sent: 12/1/2023.B3: event year only reported: 2023.D4 batch #: unknown.Additional information was requested and the following was obtained: please provide the generator event logs for each unit ¿ 1112315016, the event logs will be also update in the wo.What was the gen11 setting for the event? not information available.Is the generator being returned to service center for diagnosis / repair or will it be an onsite check? the generator was returned to the service center.Were there any error or alert screens noted for the event? there wasn't any error or alert.Investigation summary: per service manual operational and diagnostic analysis did not confirm the reported hemostasis issue.The unit passed all functional tests and is fully operational.No further investigation will be conducted on this complaint.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.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.
Event or Problem Description
It was reported that during the laparoscopy plus gastrectomy procedure, the forceps are being used and the assistant and the tip burn, which causes the patient to bleed.The surgery must immediately be converted to open and another enseal device opened.
Additional Manufacturer Narrative
(b)(4).Date sent: 12/14/2023 additional information was requested and the following was obtained: this procedure saw a total of 196 firings.Of the 196 firings, there were 27 that had the potential for burn.These saw significant abuse times, exhibited high energy and had little time to cool between activations.Of the 27, 6 were very abusive.The worst case was an activation of 18 seconds at power level 5 where 17 seconds was in att.This activation consumed 450j of energy.The other 5 had energies around 300j and att times between 8 and 11 seconds.

• 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: 18246312
• Report Number: 3005075853-2023-08926
• Device Sequence Number: 15231020
• Product Code: GEI
• UDI-Device Identifier: 10705036013952
• UDI-Public: 10705036013952
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/01/2023

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/08/2023
• Supplement Date Received by Manufacturer: 12/14/2023
• Initial Report FDA Received Date: 12/01/2023
• Supplement Report FDA Received Date: 12/14/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown