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

Catalog Number	NSLG2S35A
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/31/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a laparoscopic total prostatectomy there was a malfunction of the enseal tip, part of the jaw of the forceps broke.Increase in operating time significant risk for the patient approach put in place: removal of the misadapted tip (surgical adaptation to extract the material), change of forceps (use of another device), additional cost for the procedure, additional operating time, crisis management.Current state of the patient: important clinical risk in laparoscopic procedure.No patient impact because removal of the material concerned, but surgical adaptation to remove the material actions taken in the healthcare facility for the management of the patient: removal of the detached part of the jaw; no patient impact.
Additional Manufacturer Narrative
(b)(4).Date sent: 4/23/2026.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: what is the surgeon¿s experience with device? what anatomical structures was the device fired upon when the device issue observed? please provide details on the adaptation required to extract the broken forceps.Was patient¿s post-operative care altered in any way due to the surgical adaptation and material extraction? what is the patient¿s current status? 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.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: 5/13/2026.Additional information was requested and the following was obtained: 1.What is the surgeon's experience with this device? 1.Surgeon accustomed to the equipment, several years of use of the equipment.2.50 procedures/year with forceps 1.On which anatomical structures was the device operated when the problem was observed? 1.Problem encountered during total prostatectomy.1.Please provide details on the adaptation required to extract the broken clamp.1.Use of another gripper for gripping.1.Has the patient's post-operative care been altered in any way as a result of surgical adaptation and material extraction? 1.No change in postoperative care.1.What is the patient's current status? 1.No patient impact.

• 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, LLC.; 475 calle c; guaynabo 00969
• Manufacturer Contact: orla o'mahony ; 475 calle c; guaynabo ; 3035526892
• MDR Report Key: 24966973
• Report Number: 3005075853-2026-03088
• Device Sequence Number: 18765880
• Product Code: GEI
• UDI-Device Identifier: 10705036014515
• UDI-Public: (01)10705036014515(17)300831(10)A98W1G
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K122797
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/23/2026

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: NSLG2S35A
• Device Lot Number: A98W1G
• 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: 04/03/2026
• Supplement Date Received by Manufacturer: 04/21/2026; 05/29/2026
• Initial Report FDA Received Date: 04/23/2026
• Supplement Report FDA Received Date: 05/13/2026; 06/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/25/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown