MAUDE Adverse Event Report: BOVIE MEDICAL CORP. BOVIE MEDICAL; SUCTION COAGULATOR

Model Number	SCF12
Medical Device Problem Code	Sparking (2595)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complainint alleges, "the scf12 caused sparks when it was connected to the bovie ids-300 unit." awaiting additional information and/or return of the reported device to conclude the evaluation.
Event or Problem Description
The complainant alleges, "the scf12 caused sparks when it was connected to the bovie ids-300 unit.".
Event or Problem Description
The complainant alleges, "the scf12 caused sparks when it was connected to the bovie ids-300 unit.".
Additional Manufacturer Narrative
The complainant alleges, "the scf12 caused sparks when it was connected to the bovie ids-300 unit." product was returned from customer, then returned to supplier for further investigation.Dhr review was completed by supplier and found product in specification.Supplier also tested retained sample from this production lot.No issues found.The supplier confirmed that the device terminal and the connection of the cable wire were normal.Complaint was unable to be confirmed at this time.True root cause is unable to be determined with accuracy.Based on the above information, no further actions are required and this can be seen as the final report.If additional information is obtained that is pertinent to the investigation, a follow-up report will be submitted.

• Brand Name: BOVIE MEDICAL
• Common Device Name: SUCTION COAGULATOR
• 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: steven fox ; 3034 owen drive; antioch, TN 37013
• MDR Report Key: 18871285
• Report Number: 3007208013-2024-00010
• Device Sequence Number: 2958079
• Product Code: GEI
• UDI-Device Identifier: 00607151006570
• UDI-Public: 00607151006570
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K033003
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/07/2024

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
• Device Model Number: SCF12
• Device Lot Number: 221106026
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/16/2024
• Supplement Date Received by Manufacturer: 02/16/2024
• Initial Report FDA Received Date: 03/08/2024
• Supplement Report FDA Received Date: 06/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Sex: Unknown