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

Model Number	ETRIO335H
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Event or Problem Description
Enseal trio device failed to open jaws to seal tissue.Fda safety report id# (b)(4).

• Brand Name: ENSEAL TRIO
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ETHICON ENDO-SURGERY, INC.; cincinnati OH 45242 2839
• MDR Report Key: 14117753
• Report Number: MW5109014
• Device Sequence Number: 6245773
• Product Code: GEI
• UDI-Device Identifier: 10705036000297
• UDI-Public: (01)10705036000297
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/13/2022

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 Expiration Date: 01/31/2024
• Device Model Number: ETRIO335H
• Device Catalogue Number: ETRIO335H
• Device Lot Number: X94FOJ
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/14/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown