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

Catalog Number	NSLX125C
Medical Device Problem Codes	Failure to Read Input Signal (1581); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Insufficient Information (4580)
Date of Event	04/07/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during an unknown procedure the coagulation button of the advanced bipolar scissors device did not work.The procedure was delayed 10 minutes.Another device was used.The procedure was completed successfully.
Additional Manufacturer Narrative
(b)(4).Date sent: 5/6/2024.D4 batch #: unknown.Additional information was requested and the following was obtained: did the patient experience any adverse consequences due to this issue? patient had his spleen removed.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 actual surgical procedure the patient underwent? what was the indication for the procedure? were there any hemostasis issues during the procedure? what was the reason for the removal of the spleen? does the surgeon believe the difficulties with the device led to the removal of the spleen? if so, how/why? what is the patient¿s current condition? 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.
Additional Manufacturer Narrative
(b)(4).Date sent: 6/5/2024.D4 batch #: a9ck67.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 reactivate alert screen was displayed.Upon visual inspection of the jaws, it was found a staple was embedded at the knife channel.The staple was removed and the device was tested with the generator and passed the test.The energy output delivered from the device was verified.All tones were heard during functional testing.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 staple stuck is a routine occurrence during surgical procedures if the device is used across staples, clips or any other material than tissue and does not necessarily indicate a manufacturing defect in the device.Care should be taken not to close the jaw staples, clips or any other material than tissue, for further information on device use, can be found on the ifu.A manufacturing record evaluation was performed for the finished device batch a9ck67, and no non-conformances were identified.
Additional Manufacturer Narrative
(b)(4).Date sent: 6/14/2024.Additional information was requested and the following was obtained: i just talked with the sales rep and the surgeon confirmed her that the removal of the spleen was due to patient conditions not because of the device.What was the actual surgical procedure the patient underwent? total gastrectomy.What was the indication for the procedure? exploratory laparotomy, total gastrectomy with roux-en-y reconstruction + subtotal distal pancreatectomy with splenectomy.Were there any hemostasis issues during the procedure? yes.What was the reason for the removal of the spleen? hemostasis control is performed, however, the tissue is of poor quality and it is decided to perform distal pancreatectomy and splenectomy, medial traction of the spleen does the surgeon believe the difficulties with the device led to the removal of the spleen? no.If so, how/why? what is the patient's current condition? patient was discharged.Correction based on additional information received: h6.

• 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: 19248725
• Report Number: 3005075853-2024-03427
• Device Sequence Number: 7320954
• Product Code: GEI
• UDI-Device Identifier: 10705036015444
• UDI-Public: 10705036015444
• Combination Product (Y/N): N
• Initial Reporter Country: EC
• 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): 05/06/2024

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: NSLX125C
• Device Lot Number: A9CK67
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/18/2024
• Supplement Date Received by Manufacturer: 05/13/2024; 05/21/2024
• Initial Report FDA Received Date: 05/06/2024
• Supplement Report FDA Received Date: 06/05/2024; 06/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/23/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown