MAUDE Adverse Event Report: CARDINAL HEALTH BOVIE SURGICAL SETUP PACK ; ELECTROSURGICAL, CUTTING, COAGULATION & ACCESSORIES

Model Number	SSK9040A
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/27/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Bovie catching on fire and causing what looks like ashed and debris on pick up as well as on the bovie pencil.

• Brand Name: BOVIE SURGICAL SETUP PACK
• Common Device Name: ELECTROSURGICAL, CUTTING, COAGULATION & ACCESSORIES
• Manufacturer (Section D): CARDINAL HEALTH; waukegan IL 60085
• MDR Report Key: 7378552
• Report Number: MW5076193
• Device Sequence Number: 2311927
• Product Code: GEI
• UDI-Device Identifier: 10885425487974
• UDI-Public: (01)10885425487974
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 03/27/2018

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
• Operator of Device: Health Professional
• Device Model Number: SSK9040A
• Device Catalogue Number: SSK9040A
• Device Lot Number: 837223
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: STRL MAJOR SURGICAL SETUP BACK
• Patient Age: 65 YR