MAUDE Adverse Event Report: BOVIE MEDICAL ARGENT; DISPOSIBLE SPLIT ADULT RETURN ELECT W/3M CABLE

Catalog Number 22-ESREC

Device Problem Arcing of Electrodes (2289)

Patient Problem Burn(s) (1757)

Event Type  malfunction  

Event Description

The customer alleged: "1.We are doing quality review of the patient issue with the leep machine.When the probe was placed into the vaginal canal, prior to touching any tissue, it arced and caused a burn to the patients uterus.When investigating i found the grounding pad used mfr22-esrec was expired.Quality is asking for confirmation from the company that expired pads could cause this type of issue.Otherwise, i may have to send the machine in to be checked (again - it's been in twice and found to be fine).".

Manufacturer Narrative

Product was purchased on multiple order numbers through mckesson.Product was sold to end user on an unknown date.Customer reached out to ask if 22-esrec can cause burns away from grounding site, as they had patient receive burns while using the pad.They had found that the pad was used, was expired, which qued the question.Customer was asked multiple questions on 9/12/2022 on 10/6/2022 customer gave the following information about the event: - pad had expired on 08/10/2022 and was used for the procedure - customer was unaware of purchasing information - product lot number was 2019-08-10, no inspection prior to surgery.- physician was activating the accessory prior to making contact with the cauterization area; 1-2mm from the cervix.Leep procedure - generator was on power settings 40 watts coagulation - physician was experiencing activation issues with the handpiece/generator.Physician activated the device without touching the patient, and the electrode arced and burned the patient near the hymen.- 2mm burn site distal vagina - this was the just after the first cut using the device - a loop electrode was used with unknown brand or product number.- patient was on a padded surgery table with grounding pad complaint denied.Root cause is determined to be user error in: - using the loop electrode in coagulation mode.According to mc-17782, ifu for bovie loop electrodes, the device is only intended to be used in cut or blend mode.Use of coag may cause a breakage of the loop wire.- activating the device prior to making contact with intended activation site.Per the ifu - "activate the electrosurgical unit only when you are ready to deliver electrosurgical current and the active tip is in view and near target tissue.Deactivate the electrosurgical unit before the tip leaves the surgical site." as the generator was powered up to 40watts, the electricity traveled the path of least resistance, and arced to the grounded patient.It is not believed the grounding pad had any influence on this complaint investigation.This is the first complaint of its kind for this part code.Based on the above information, no further actions are required and this can be seen as the final report.If additional information is obtained that alleges any additional patient involvement or need for corrective actions, a follow up report will be submitted.

• Brand Name: ARGENT
• Type of Device: DISPOSIBLE SPLIT ADULT RETURN ELECT W/3M CABLE
• Manufacturer (Section D): BOVIE MEDICAL; 5115 ulmerton road; clearwater FL 33760
• Manufacturer (Section G): BOVIE MEDICAL; 5115 ulmerton road; clearwater FL 33760
• Manufacturer Contact: andy ferrell ; 3034 owen drive; antioch, TN 37013 ; 6159645553
• MDR Report Key: 15565809
• MDR Text Key: 306927967
• Report Number: 3007208013-2022-00043
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10607151563537
• UDI-Public: 10607151563537
• Combination Product (y/n): N
• 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: 10/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/10/2022
• Device Catalogue Number: 22-ESREC
• Device Lot Number: 2019-8-10
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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