MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ENSEAL X1 CURVED 25CM SHAFT; ELECTROSURGICAL CUTTING & COAGULATION & ACCESSORIES

Catalog Number	NSLX125C
Medical Device Problem Codes	Difficult to Open or Close (2921); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	11/28/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Date sent: 12/19/2024 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 information was requested and the following was obtained: 1.How was the bleeding controlled? 2.Was there any other action taken for the procedure? 3.Did the procedure have to be converted to open? 4.Did the patient need to have a blood transfusion? 5.Did the patient need any different type of post op care due to the bleeding/oozing? 6.Was there any patient consequence or change in the post-operative care of the patient as a result of the event? -i have not had any feedback from the customer.
Additional Manufacturer Narrative
(b)(4).Date sent: 12/11/2024.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: how was the bleeding controlled? was there any other action taken for the procedure? did the procedure have to be converted to open? did the patient need to have a blood transfusion? did the patient need any different type of post op care due to the bleeding/oozing? was there any patient consequence or change in the post-operative care of the patient as a result of the event? 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.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance were identified.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 a lap mod radical hysterectomy right salpingo oophorectomy, omentectomy, debulking procedure, when sealing over the ovarian artery, the knife blade would not depress.Surgeon tried to open the handle and tried to depress the cut button, device jaws would not open.Surgeon pulled to remove the device off the uterine artery which caused bleeding.Surgeon was able to repair and stop bleeding.The procedure was completed successfully.
Additional Manufacturer Narrative
(b)(4).Date sent: 12/24/2024.D4 batch #: c9eg9a.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 revealed that the device was received with no apparent damage.The device was tested on the generator and passed all functional testing.The energy output delivered from the device was verified.All tones were heard during functional testing.The device was tested with the test media and no anomalies were found.No issues were noted with the opening and closing of the jaws.There were no anomalies noted with the functionality of the device.As part of the quality process, all devices are manufactured, inspected, and released to approved specifications.The event described could not be confirmed as the device performed without any difficulties noted.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 c9eg9a, and no non-conformances were identified.

• Brand Name: ENSEAL X1 CURVED 25CM SHAFT
• 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, INC. (CINCINNATI)
• Manufacturer Contact: kate karberg ; 475 calle c; guaynabo ; 3035526892
• MDR Report Key: 20905988
• Report Number: 3005075853-2024-09426
• Device Sequence Number: 19835517
• Product Code: GEI
• UDI-Device Identifier: 10705036015444
• UDI-Public: (01)10705036015444(17)290531(10)C9EG9A
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K172580
• 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,Followup
• Report Date (Section B): 12/11/2024

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: NSLX125C
• Device Lot Number: C9EG9A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/28/2024
• Supplement Date Received by Manufacturer: 12/13/2024; 12/21/2024
• Initial Report FDA Received Date: 12/11/2024
• Supplement Report FDA Received Date: 12/19/2024; 12/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GENERATOR
• Patient Sex: Unknown