MAUDE Adverse Event Report: BOVIE MEDICAL CORP MCKESSON; BALL ELECTRODE

Model Number	465
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/20/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pictures of the used device were provided showing the ball electrode covered in black material and the insulation appears to be melting heavily, close to the ball tip.The product was activated for 30 seconds on power setting coag 40 watts.The true total time of activation is unknown.The customer was using a bovie pencil from an unknown part number with a wallach quantum 2000 biovac generator.The customer stated that no material fell into the patient and there was no other patient impact.Per the product ifu, "confirm proper electrosurgical setting before proceeding with the surgery.Use the lowest appropriate setting to achieve the desired effect.The root cause was determined to be that the power settings were too high for the extended activation time.A dhr review was completed.There were no noted nonconformities during manufacturing and processing of this product and lot number.All items were noted as within manufacturing specifications from the manufacturing location.This is the first complaint of its kind for this part number.Based on the information above, no further actions are required.This can be seen as the final report.If additional information is obtained that alleges any additional patient involvement or need for corrective actions, a follow up report will be submitted.The submission is passed due as we recently became aware that the original submission was not accepted due to an old version of esubmitter.
Event or Problem Description
The customer alleged that product melted while in a procedure.There was no harm to the patient or the user.

• Brand Name: MCKESSON
• Common Device Name: BALL ELECTRODE
• Manufacturer (Section D): BOVIE MEDICAL CORP; 5115 ulmerton road; clearwater FL 33760
• Manufacturer (Section G): BOVIE MEDICAL CORP; 5115 ulmerton road; clearwater FL 33760
• Manufacturer Contact: brandi meath ; 3034 owen drive; antioch, TN 37013 ; 6159645290
• MDR Report Key: 13538311
• Report Number: 3007208013-2021-00030
• Device Sequence Number: 11957590
• Product Code: HGI
• UDI-Device Identifier: 20612479210237
• UDI-Public: 20612479210237
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K931338
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/14/2021

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 Expiration Date: 06/01/2025
• Device Model Number: 465
• Device Catalogue Number: 465
• Device Lot Number: 0621A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/20/2021
• Initial Report FDA Received Date: 02/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown