MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ENSEAL 45 CM SHAFT, CURVED JAW; ELECTROSURGICAL CUTTING & COAGULATION & ACCESSORIES

Catalog Number	NSLX145C
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/11/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during unknown procedure, 6 hours after the procedure started, the tip of the device, the ratchet, could not be opened holding the bladder.The device was used as usual.The tissue which the device hold was too hard and thick.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: 6/24/2024 d4 batch #: unknown.Additional information was obtained: surgical method:robot-assisted radical cystectomy the patient is stable after the surgery.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: 7/22/2024.D4 batch #: a9ct2r.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.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.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.A manufacturing record evaluation was performed for the finished device batch a9ct2r, and no non-conformances were identified.

• Brand Name: ENSEAL 45 CM SHAFT, CURVED JAW
• 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: 19602635
• Report Number: 3005075853-2024-04666
• Device Sequence Number: 11639262
• Product Code: GEI
• UDI-Device Identifier: 10705036015499
• UDI-Public: (01)10705036015499(11)230415(17)280331(10)A9CT2R(21)23105-0371
• 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): 06/24/2024

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: NSLX145C
• Device Lot Number: A9CT2R
• 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: 06/12/2024
• Supplement Date Received by Manufacturer: 07/02/2024
• Initial Report FDA Received Date: 06/24/2024
• Supplement Report FDA Received Date: 07/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/15/2023
• 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
• Patient Sex: Unknown