MAUDE Adverse Event Report: BOVIE MEDICAL CORP MCKESSON; DISPOSABLE GROUNDING PAD

Model Number 22-ESREC

Device Problem No Device Output (1435)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  malfunction  

Manufacturer Narrative

Customer believes they started using these pads in first of 2022.Customer is using the pads with generators icc80, serial # (b)(4).There is currently no validation for compatibility to this competitor generator.Customer did not retain original samples from investigation.Remainder of boxed product was requested for return.Product was received through the rma room on 3/8/2023 nad tested with in house generator.Devices returned were in new condition in new packaging.Products were removed from packaging and applied to test generator a1250.Cord connection was snug and fit as intended.When inserted, the grounding pad alarm went away on the generator (per specification).The gel of pad was reviewed to confirm stickiness.Product was in specification and was not easily removed when applied to bare skin.Complaint was unable to be confirmed from returned samples.True root cause is unable to be determined with accuracy.It may be possible the customer generator has a slight tolerance stack on the pads connector to our bovie product, causing a bad connection between the pads and unit.This is the first complaint recorded for this occurrence for the product code.Based on the information provided, no further actions are required.This can be seen as the final report.If additional information is obtained that alleges any additional patient involvement or information pertinent to the investigation, a follow up report will be submitted.

Event Description

The customer alleged that the grounding pad causing an error on the machine, which stops the doctor's ability to cauterize.Therefore, it is causing unnecessary bleeding.

• Brand Name: MCKESSON
• Type of Device: DISPOSABLE GROUNDING PAD
• 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: 16568361
• MDR Text Key: 311568862
• Report Number: 3007208013-2023-00012
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10612479209203
• UDI-Public: 10612479209203
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K092761
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/16/2023

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
• Device Operator: Health Professional
• Device Model Number: 22-ESREC
• Device Catalogue Number: 22-ESREC
• Device Lot Number: CEG1L008
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2023
• Initial Date Manufacturer Received: 02/21/2023
• Initial Date FDA Received: 03/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/22/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1