MAUDE Adverse Event Report: BOVIE MEDICAL CORP BOVIE; SUCTION COAGULATOR

Model Number	SCH10
Health Effect - Clinical Code	Superficial (First Degree) Burn (2685)
Type of Reportable Event	Malfunction
Event or Problem Description
The customer alleged that while using sch10 the surgeon received a light burn through his glove to his finger while depressing the cautery switch on th pencil.He felt a "zing" and immediately released the switch.
Additional Manufacturer Narrative
Customer gave the following information about use of the device: product is not available for return for further investigation.No pictures are available of the physicians burns.This is one of the first few times the customer is using the product as it is a replacement product for one of their standard used items.Generator used with accessory was megadyne mega power ref 1000 with sn (b)(4).Power settings during use were 0/40.Customer was using a coblator with the generator.(as a note- coblators are used for ablation, resection, and coagulation of soft tissue and hemostasis of blood vessels in otorhinolaryngology (ent) surgery).Customer stated they were grounding the patient using a grounding pad and the physician was not holding any metal instruments.Customer was using the device for 15-20 seconds at a time during a t and a surgery.The surgery was able to be completed successfully, however, about 15-20 mins into the surgery, the physician received a shock from the button on the sch10.Customer was asked further questions about the coblator on 6-16-2022: customer states coblator was not active during the shock experienced by the physician.Coblator information - coblator procise xp wand - smith and nephew (eica8872-01) for arthrocare ent.The customers competitor product similar to sch10 was a megadyne reg# 004125 with lot 210093.Ifu for customer generator, megadyne coagulator, and sch10 attached.Megadyne coagulator ifu does not call out a maximum kvp-p setting, however does have a minimum of 5.5 kvp-p.Sch10 has a maximum kvp-p of 9kvp-p.Both ifu's state to use the lowest possible power setting to achieve the desired affect.Complaint is unable to be confirmed without return of product.True root cause is unable to be determined at this time.However, it may be possible that after multiple uses of the device for activations of 15-20 seconds at a time at power setting 40 coag, may have exceeded the power rating on the sch10.This is the first complaint recorded for this product code for this occurrence.Based on the information received, no further actions are required.This can be seen as the final report.If additional information is received that alleges any additional patient or user involvement or the need for corrective actions, a follow up report will be submitted.

• Brand Name: BOVIE
• Common Device Name: SUCTION COAGULATOR
• 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: 14854416
• Report Number: 3007208013-2022-00025
• Device Sequence Number: 6290038
• Product Code: GEI
• UDI-Device Identifier: 00607151006532
• UDI-Public: 00607151006532
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• PMA/510(K) Number: K033003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 06/29/2022

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: 03/09/2024
• Device Model Number: SCH10
• Device Catalogue Number: SCH10
• Device Lot Number: 210806030
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/14/2022
• Initial Report FDA Received Date: 06/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/09/2021
• 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: Disability
• Patient Sex: Unknown