MAUDE Adverse Event Report: BOVIE MEDICAL CORPORATION WECK; ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES

Model Number	809319
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/21/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Weck disposable 6" extended 3/4" blade electrode was used by surgeon.Upon inspection by surgical tech, a portion of the bovie tip was not intact.Bovie tip was replaced and used without further incident.Both the broken bovie and the replacement bovie were retained for inspection.No harm came to the patient.Images of the broken device were obtained and the device will be returned to the manufacturer for failure analysis.Manufacturer response for electrosurgical, cutting coagulation accessories, weck (per site reporter).The device will be returned for failure analysis.Any further updates from the manufacturer will be shared.

• Brand Name: WECK
• Common Device Name: ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES
• Manufacturer (Section D): BOVIE MEDICAL CORPORATION; 5115 ulmerton road; clearwater FL 33760
• MDR Report Key: 8342832
• Report Number: 8342832
• Device Sequence Number: 11220889
• Product Code: GEI
• UDI-Device Identifier: 00607151009809
• UDI-Public: (01)00607151009809
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/30/2019
• Report Date (Section F): 01/30/2019

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: 809319
• Device Catalogue Number: 809319
• Device Lot Number: 0518E
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Device Age: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 02/15/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 68
• Date Report Sent to FDA: 01/30/2019