MAUDE Adverse Event Report: BOVE MEDICAL CORPORATION ARGENT MCKESSON; COATED EXTENDED BLADE

Model Number 22-ES39T

Device Problem Thermal Decomposition of Device (1071)

Patient Problem Burn, Thermal (2530)

Event Date 11/19/2020

Event Type  malfunction  

Manufacturer Narrative

The lot number of the device is unknown as it is a single use device and the packaging was discarded.The device was returned to symmetry surgical and was confirmed to be burnt through the insulation.The device was sent to the manufacturing location for further evaluation on (b)(6) 2020.There has been a total of (b)(4) sold of this product code with no additional complaint recorded for this occurrence.A follow up report will be completed once the investigation has been completed.

Event Description

During a procedure that metal part of the device burned through the insulation and caused a small burn on the patient's skin.The patient did not require an medical intervention and will not have any permanent affect on the patient.

Manufacturer Narrative

The root cause was determined to be the result of misuse.Per the supplier investigation, it was noted that the device is bent.It is believed that the bend of the electrode in combination with a higher than recommended power setting caused the burn through the insulation.The customer was referred to the ifu statement "always use the lowest power setting that achieves the desired surgical effect.Use the active electrode for the minimum time necessary in order to reduce the possibility of unintended burn injury".The lot number of the device was never determined, therefore the device history record could not be reviewed.Based on the above information, 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: ARGENT MCKESSON
• Type of Device: COATED EXTENDED BLADE
• Manufacturer (Section D): BOVE MEDICAL CORPORATION; 5115 ulmerton road; clearwater FL 33760
• MDR Report Key: 11069454
• MDR Text Key: 224259592
• Report Number: 3007208013-2020-00041
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 20612479210107
• UDI-Public: 20612479210107
• Combination Product (y/n): N
• PMA/PMN Number: K093025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 01/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 22-ES39T
• Device Catalogue Number: 22-ES39T
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2021
• Date Manufacturer Received: 12/03/2020
• Patient Sequence Number: 1