MAUDE Adverse Event Report: STRYKER INSTRUMENTS DISPOSABLE SUCTION BOVIE; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number 0703-046-000

Patient Problem Superficial (First Degree) Burn (2685)

Event Date 12/13/2023

Event Type  malfunction  

Event Description

While plugging neptune smoke evacuation pencil, the device activated itself and landed patient causing a small burn.Entire bovie and handpiece removed from room.

• Brand Name: DISPOSABLE SUCTION BOVIE
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): STRYKER INSTRUMENTS; portage MI 49002
• MDR Report Key: 18436801
• MDR Text Key: 331898545
• Report Number: MW5149730
• Device Sequence Number: 1
• Product Code: GEI
• 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: 12/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0703-046-000
• Device Lot Number: 62296668
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Age: 36 YR
• Patient Sex: Female
• Patient Weight: 92 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White