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	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Date sent: 1/28/2026.B3: event year only reported: 2025.D4 batch #: a98x93.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 determined that the device was returned with the outer distal tube detached and it was returned.Additionally, the closure pin for the jaws was missing and not returned.Due to the condition of the device returned not all functional testing could be performed.Additionally, a photo was provided and they showed the condition of the reported event.Based on the information currently available, a product issue was identified during the investigation of the sample received.This product issue will be addressed through ethicon endo surgery¿s quality system.A manufacturing record evaluation was performed for the finished device lot/batch a98x93, and no non-conformances were identified.
Event or Problem Description
It was reported that a piece near the articulation joint came off inside the patient during the procedure.They retrieved the broken piece.This was a bariatric revision sleeve to bypass.No adverse impact patient/user.

• 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 ; * 00969
• Manufacturer (Section G): ETHICON ENDO SURGERY, INC. (CINCINNATI)
• Manufacturer Contact: orla o'mahony ; 475 calle c; guaynabo ; * ; 3035526892
• MDR Report Key: 24201745
• Report Number: 3005075853-2026-00855
• Device Sequence Number: 13170597
• Product Code: GEI
• UDI-Device Identifier: 10705036015499
• UDI-Public: (01)10705036015499(17)300930(10)A98X93
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/28/2026

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: NSLX145C
• Device Lot Number: A98X93
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/26/2026
• Initial Report FDA Received Date: 01/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/02/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: GENERATOR.
• Patient Sex: Unknown