MAUDE Adverse Event Report: BUGBEE ELECTRODE; MONOPOLAR FLEXIBLE ELECTRODE

Model Number UNIT 5716174

Device Problem Fire (1245)

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

Event Date 06/19/2019

Event Type  Injury  

Event Description

The cord popped off the bugbee monopolar electrode hand piece and a small fire ignited on the cord.The fire was put out and the cord was disconnected from the electrosurgical unit.No harm to the pt.

• Brand Name: BUGBEE ELECTRODE
• Type of Device: MONOPOLAR FLEXIBLE ELECTRODE
• MDR Report Key: 8775154
• MDR Text Key: 150547735
• Report Number: 8775154
• Device Sequence Number: 1
• Product Code: FAS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNIT 5716174
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/19/2019
• Event Location: Hospital
• Date Report to Manufacturer: 06/21/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/28/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR