MAUDE Adverse Event Report: BOVIE MEDICAL CORP. BOVIE MEDICAL; LOOP ELECTRODE

Model Number	ES10
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Event or Problem Description
The complainant alleges, "the loop is breaking during procedure".
Additional Manufacturer Narrative
Awaiting additional information and/or return of the reported device to complete the investigation.
Event or Problem Description
The complainant alleges, "the loop is breaking during procedure".
Additional Manufacturer Narrative
The complaint was unable to be determined as the customer was contacted multiple times and never responded with additional information and the device was not available for return.True root cause is unable to be determined with accuracy at this time.If additional information is obtained that is pertinent to the investigation or provides additional details a follow-up report will be provided.Until such time, this can be seen as the final report.

• Brand Name: BOVIE MEDICAL
• Common Device Name: LOOP 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: steven fox ; 3034 owen drive; antioch, TN 37013
• MDR Report Key: 19533480
• Report Number: 3007208013-2024-00027
• Device Sequence Number: 7704831
• Product Code: HGI
• UDI-Device Identifier: 00607151056100
• UDI-Public: 00607151056100
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/12/2024

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: ES10
• Device Lot Number: 1222Z
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/23/2024
• Supplement Date Received by Manufacturer: 05/23/2024
• Initial Report FDA Received Date: 06/13/2024
• Supplement Report FDA Received Date: 07/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown