MAUDE Adverse Event Report: BOVIE MEDICAL CORP ARGENT MCKESSON; COATED STANDART BLADE ELECTRODE

Model Number	22-ES58T
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	09/15/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The customer alleged that the product is sticking when activated, which is causing more bleeding.Additionally, the product gets pulled out of the handpiece and into the surgical field.
Additional Manufacturer Narrative
The device is being returned for our evaluation.We have not received the part yet.The customer was also asked multiple questions regarding the usage of the device.There has been a total of (b)(4) electrodes sold since 2018 with no additional complaints recorded for this occurrence.A follow up report will be submitted once we have received additional information or completed our investigation.This submission is passed due as we recently became aware that our submissions were not being accepted due to an old version of esubmitter.
Additional Manufacturer Narrative
The customer was unable to answer additional questions regarding the event as the nurse that experienced the issue is no longer with the facility.The product was returned in an unused state in sterile packaging.The product was evaluated for the following: review of coating material at the tip (passed - no abrasions on the tip and the coating was smooth and even.).Review for flashing (passed , no flashing found).Measurement of insertion end of electrode (passed - 2 samples were inspected at four locations each.All measured at 2.37mm with a caliper.This measurement is within conformance per the product specifications.Insertion into an espr2, esp1, and a902 handpiece (passed - all handpieces held the electrodes without issues).The complaint could not be confirmed and a device that was actually used and causing the sticking was not returned.This can be seen as the final report.If additional information is obtained that alleges any addition patient involvement or need for corrective actions, a follow up report will be submitted.This submission is passed due as we recently became aware that the orignal submission was not accepted due to an old version of esubmitter.

• Brand Name: ARGENT MCKESSON
• Common Device Name: COATED STANDART BLADE 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: brandi meath ; 3034 owen drive; antioch, TN 37013 ; 6159645290
• MDR Report Key: 13537117
• Report Number: 3007208013-2021-00031
• Device Sequence Number: 17406749
• Product Code: GEI
• UDI-Device Identifier: 20612479210084
• UDI-Public: 20612479210084
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K093025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/16/2021

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 Expiration Date: 09/01/2024
• Device Model Number: 22-ES58T
• Device Catalogue Number: 22-ES58T
• Device Lot Number: 0920E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/29/2021
• Supplement Date Received by Manufacturer: 09/29/2021
• Initial Report FDA Received Date: 02/15/2022
• Supplement Report FDA Received Date: 02/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown