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

Model Number 16ETRIO335H

Device Problem Protective Measures Problem (3015)

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

Event Date 01/15/2019

Event Type  malfunction  

Event Description

Surgeon stated that the trigger is malfunctioning during the procedure.Requested new device, which worked 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: 8296554
• MDR Text Key: 134727222
• Report Number: 8296554
• Device Sequence Number: 1
• Product Code: HGI
• UDI-Device Identifier: 10705036000297
• UDI-Public: (01)10705036000297
• 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: 01/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2019
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 16ETRIO335H
• Device Catalogue Number: ETRIO335H
• Device Lot Number: R94X2Y
• 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: 01/22/2019
• Event Location: Hospital
• Date Report to Manufacturer: 02/01/2019
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 30295 DA
• Patient Weight: 89