MAUDE Adverse Event Report: BOVIE MEDICAL CORPORATION BOVIE; HIGH TEMP CAUTERY

Model Number AA01

Device Problems Self-Activation or Keying (1557); Failure to Shut Off (2939)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/01/2020

Event Type  malfunction  

Manufacturer Narrative

The product is being returned for evaluation.The dhr record was reviewed for this lot number with no noted noncomformities during the manufacturing and processing of this product.All items were noted as within manufacturing specifications from the manufacturer.(b)(4).A follow up report will be submitted once the product is returned for evaluation.

Event Description

The customer was preparing the device when the cautery became active without touching the buttons.The cautery would not turn off and the batteries had to be removed.There was no harm to the patient or the staff.

Manufacturer Narrative

Only the manufacturing date on the label was recorded.The sterile lot number of the device was not provided.--corrected the lot number to 9-24-2019.The customer was given a return material authorization(rma) form and a shipping label to return the device.However, it was never received.The tracking number on the shipping label was never used and the customer could not confirm the carrier information to track it.The device history record could not be reviewed as the sterile lot numberr was not provided.The complaint cannot be confirmed without the return of the device, and a root cause cannot be determined.(b)(4).This can be seen as the final report.If additional information is obtained that alleges any additional patient involvement or the need for corrective actions, a follow up report will be submitted.

• Brand Name: BOVIE
• Type of Device: HIGH TEMP CAUTERY
• Manufacturer (Section D): BOVIE MEDICAL CORPORATION; 5115 ulmerton road; clearwater, fl
• MDR Report Key: 10302480
• MDR Text Key: 200816578
• Report Number: 3007208013-2020-00019
• Device Sequence Number: 1
• Product Code: HQP
• UDI-Device Identifier: 00607151011017
• UDI-Public: 00607151011017
• Combination Product (y/n): N
• PMA/PMN Number: K121441
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 07/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/01/2022
• Device Model Number: AA01
• Device Catalogue Number: AA01
• Device Lot Number: 09-24-2019
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/01/2020
• Initial Date FDA Received: 07/21/2020
• Supplement Dates Manufacturer Received: 07/01/2020
• Supplement Dates FDA Received: 08/14/2020
• Patient Sequence Number: 1