MAUDE Adverse Event Report: BOVIE MEDICAL CORPORATION BOVIE; UNIT, CAUTERY, THERMAL, BATTERY-POWERED

Model Number AA00

Device Problems Defective Device (2588); Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/21/2022

Event Type  malfunction  

Event Description

Sterile low temp fine tip cautery was defective.Part of the tip was detached.Ref# aa00, lot# 0921z.Item was opened in the sterile backbench prep table for the endograft build.Item placed in the metal cabinet.Apsm updated.

• Brand Name: BOVIE
• Type of Device: UNIT, CAUTERY, THERMAL, BATTERY-POWERED
• Manufacturer (Section D): BOVIE MEDICAL CORPORATION; 5115 ulmerton rd; clearwater FL 33760
• MDR Report Key: 15814083
• MDR Text Key: 303815221
• Report Number: 15814083
• Device Sequence Number: 1
• Product Code: HQP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: AA00
• Device Catalogue Number: AA00
• Device Lot Number: 0921Z
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/09/2022
• Event Location: Hospital
• Date Report to Manufacturer: 11/17/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1