MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC ENSEAL X1; ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES

Model Number	NSLX120L
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Surgeon was using the device.The device was not closing and giving error message.Device was removed and replaced with new product.

• Brand Name: ENSEAL X1
• Common Device Name: ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC; 475 calle c; guaynabo PR 00969
• MDR Report Key: 20722860
• Report Number: 20722860
• Device Sequence Number: 3783045
• Product Code: GEI
• UDI-Device Identifier: 10705036015024
• UDI-Public: (01)10705036015024
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 11/11/2024
• Report Date (Section F): 11/11/2024

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
• Device Model Number: NSLX120L
• Device Catalogue Number: NSLX120L
• Device Lot Number: Y7028K
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 11/19/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/19/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose
• Date Report Sent to FDA: 11/11/2024