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

Catalog Number	E15644
Medical Device Problem Code	Melted (1385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
The customer alleged that the ball tip electrode charred and the plastic melted during a laparoscopic procedure.There was no harm to the patient.
Additional Manufacturer Narrative
No further information has been provided by the customer.We are continuing to follow up.This is the first complaint of its kind for this product number in the last 2.8 year of complaint review = low if additional information is received that is pertinent to the investigation, a supplemental report will be submitted.

• Brand Name: VALLEYLAB
• 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
• MDR Report Key: 18176590
• Report Number: 3007208013-2023-00055
• Device Sequence Number: 18064188
• Product Code: GEI
• UDI-Device Identifier: 10607151009868
• UDI-Public: 10607151009868
• 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): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/20/2023

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: 10/01/2025
• Device Catalogue Number: E15644
• Device Lot Number: X1021K
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/26/2023
• Initial Report FDA Received Date: 11/20/2023
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown