MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, INC. ENSEAL X1 TISSUE SEALER; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number NSLX137S

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/27/2022

Event Type  malfunction  

Event Description

Enseal x1 tissue sealer not working properly per physician.Fda safety report id# (b)(4).

• Brand Name: ENSEAL X1 TISSUE SEALER
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ETHICON ENDO-SURGERY, INC.
• MDR Report Key: 15216913
• MDR Text Key: 297953507
• Report Number: MW5111444
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NSLX137S
• Device Catalogue Number: NSLX137S
• Device Lot Number: X9515R
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 67 YR