MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC ENSEAL; ELECTROCAUTERY, GYNECOLOGIC (AND ACCESSORIES)

Model Number NSLX12OL

Device Problem Difficult to Open or Close (2921)

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

Event Date 04/06/2019

Event Type  malfunction  

Event Description

Tissue sealer did not close properly.

• Brand Name: ENSEAL
• Type of Device: ELECTROCAUTERY, GYNECOLOGIC (AND ACCESSORIES)
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC; 4545 creek rd.; cincinnati OH 45242
• MDR Report Key: 9151951
• MDR Text Key: 161076587
• Report Number: 9151951
• Device Sequence Number: 1
• Product Code: HGI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2019
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: NSLX12OL
• Device Lot Number: T9208C
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/07/2019
• Event Location: Hospital
• Date Report to Manufacturer: 10/03/2019
• Type of Device Usage: N
• Patient Sequence Number: 1