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

Catalog Number	NSLX137C
Medical Device Problem Codes	Failure to Read Input Signal (1581); Activation, Positioning or Separation Problem (2906); Difficult to Open or Close (2921); Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/15/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4) date sent: 5/4/2026 d4 batch #: unknown d4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.D4: udi: the expiration date is currently not available.Therefore, the full udi is currently not available.Additional information was obtained: the procedure was a total laparoscopic hysterectomy.An electric knife was used to complete the case.The device was used in a case of total laparoscopic hysterectomy.While the posterior vaginal wall was being clamped and cut with the device, the clamped-in matter could not be peeled off, but it was just before removing at the very end, so an incision was performed with an electric scalpel below the clamped area, and the surgery itself was completed without any problems.There was no bleeding, the patient's condition was no problem, and the patient is stable post-operatively.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.The lot/batch was not provided; therefore, the manufacturing records evaluation could not be performed.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 ob-gyn surgery, the jaws of the enseal became not to be opened during the final hemostasis.Clicking the ratchet didn't open, and the button also didn't function.It's unclear if it's related to the jaw opening/closing malfunction, but before the malfunction occurred, an unknown error message was displayed on the gen 11.Another device was used to complete the case.There were no adverse consequences to the patient.No further information is available.

• Brand Name: ENSEAL
• 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: orla o'mahony ; 475 calle c; guaynabo ; 3035526892
• MDR Report Key: 25073516
• Report Number: 3005075853-2026-03368
• Device Sequence Number: 10402659
• Product Code: GEI
• UDI-Device Identifier: 10705036015468
• UDI-Public: (01)10705036015468(17)300930(10)A9900D
• 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): 05/04/2026

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: NSLX137C
• 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: 04/16/2026
• Supplement Date Received by Manufacturer: 05/18/2026
• Initial Report FDA Received Date: 05/04/2026
• Supplement Report FDA Received Date: 06/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/15/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown