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

Catalog Number	NSLX125C
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4) date sent: 3/26/2025 d4 batch #: unknown.Additional information was obtained: the jaws could be removed by cutting tissue around the jaws.There was no tissue damage, and the procedure was completed successfully.The patient is stable.The device was returned with jaws closed, so if the jaws are open when the device arrives, it may have been subjected to shock during transportation.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 an unknown procedure, the device could be used early in procedure, but in the middle of the procedure, the jaws could not open with holding tissue.No pieces were fell into the patient.Gen11 was used.Another device was used to complete the case.There were no adverse consequences to the patient.No further information is available.
Additional Manufacturer Narrative
(b)(4).Date sent: 4/22/2025.D4 batch #: c9dp2y.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 dry body fluids.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.No issues were noted with the opening and closing of the jaws.There were no anomalies noted with the functionality of the device.It is possible that excessive body fluids influence the opening and closing of the jaws.The accumulation of body fluids is a routine occurrence during surgical procedures and does not necessarily indicate a manufacturing defect in 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 c9dp2y, 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: 21698402
• Report Number: 3005075853-2025-02221
• Device Sequence Number: 8774251
• Product Code: GEI
• UDI-Device Identifier: 10705036015444
• UDI-Public: (01)10705036015444(17)290228(10)C9DP2Y
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Report Date (Section B): 03/26/2025

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: C9DP2Y
• 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: 03/13/2025
• Supplement Date Received by Manufacturer: 04/03/2025
• Initial Report FDA Received Date: 03/26/2025
• Supplement Report FDA Received Date: 04/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/14/2024
• 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