MAUDE Adverse Event Report: STERIS CORPORATION V. MUELLER; UNIPOLAR BOVIE CORD

Model Number	88-9199
Medical Device Problem Code	Fire (1245)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that the foot pedal of their unipolar bovie cord emitted a small flame.The damage was contained to a small area.No report of injury.
Additional Manufacturer Narrative
The device subject of the reported event was returned to the supplier for evaluation.The investigation is currently in process.A follow-up report will be submitted once additional information becomes available.
Additional Manufacturer Narrative
The device subject of the reported event was returned to the supplier for evaluation.Upon evaluation, it was discovered that one end of the unipolar bovie cord as well as the internal wiring was black and appeared to be burned.The root cause of the reported event can be attributed to significant wear to the cord from usage over time resulting in damage to the internal wiring of the cord and an electrical arc.Contrary to the reported event, there was no flame.The device subject of the reported event was manufactured in 2016 and was more than 8 years old at the time of the event.The bovie cord instructions for use (ifu) states, "inspect every device before each use.Damaged electrosurgical devices may cause electrical burns to the patient or physician." the ifu further states, "each reusable device is designed to withstand a minimum of 20 sterilization cycles when properly cared for and sterilized according to the instructions below." in-service training was offered on properly inspecting the device prior to each use to confirm the device is not worn or damaged; however, the user facility declined.No additional issues have been reported.

• Brand Name: V. MUELLER
• Common Device Name: UNIPOLAR BOVIE CORD
• Manufacturer (Section D): STERIS CORPORATION; 5960 heisley rd; mentor 44060
• Manufacturer (Section G): STERIS CORPORATION; 5960 heisley rd.; mentor OH 44060
• Manufacturer Contact: daniel davy ; 5960 heisley rd; mentor, OH 44060 ; 4403927453
• MDR Report Key: 20798315
• Report Number: 1527821-2024-00024
• Device Sequence Number: 12733341
• Product Code: GEI
• UDI-Device Identifier: 10885403154805
• UDI-Public: (01)10885403154805(10)100552
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 11/27/2024

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: 88-9199
• Device Catalogue Number: 889199
• Device Lot Number: (10)100552
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/01/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/27/2024
• Supplement Report FDA Received Date: 03/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown