MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, INC. LAPAROSCOPIC TISSUE SEALER G2; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Lot Number	A9DZ5F
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/16/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Enseal failed to articulate or close jaw.

• Brand Name: LAPAROSCOPIC TISSUE SEALER G2
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ETHICON ENDO-SURGERY, INC.
• MDR Report Key: 18588759
• Report Number: MW5150759
• Device Sequence Number: 17857017
• Product Code: GEI
• UDI-Device Identifier: 10705036014515
• UDI-Public: (01)10705036014515
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Voluntary
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 01/22/2024

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
• Operator of Device: Health Professional
• Device Lot Number: A9DZ5F
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/25/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown