MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, INC. ETHICON ENSEAL LARGE JAW TISSUE SEALER; ELECTROCAUTER, GYNECOLOGY (AND ACCESSORIES)

Model Number NSLX120L

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/08/2019

Event Type  malfunction  

Event Description

Device quit working mid-procedure had to be replaced with new handpiece.Fda safety report id# (b)(4).

• Brand Name: ETHICON ENSEAL LARGE JAW TISSUE SEALER
• Type of Device: ELECTROCAUTER, GYNECOLOGY (AND ACCESSORIES)
• Manufacturer (Section D): ETHICON ENDO-SURGERY, INC.
• MDR Report Key: 9349136
• MDR Text Key: 167383584
• Report Number: MW5091197
• Device Sequence Number: 1
• Product Code: HGI
• UDI-Device Identifier: 10705036015024
• UDI-Public: (01)10705036015024
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 11/18/2019

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 Operator: Health Professional
• Device Expiration Date: 07/31/2021
• Device Model Number: NSLX120L
• Device Catalogue Number: NSLX120L
• Device Lot Number: T9473H
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/19/2019
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Weight: 122