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

Model Number	SCH10
Health Effect - Clinical Code	Superficial (First Degree) Burn (2685)
Date of Event	06/23/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is the second occurrence from this customer with the same surgeon.The customer has returned the coagulatory for evaluation.We are sending the device to the manufacturing location for a full evaluation.(b)(4).A follow up report will be submitted once the evaluation of the returned device has been completed.
Event or Problem Description
The customer alleges that the sch10 was being used and caused a superficial burn to the physicians finger while depressing the handswitch.
Additional Manufacturer Narrative
The device was returned to the manufacturing location for further investigation.The complaint was able to be confirmed through main frequency hi-pot test 4243 vrms for 30 seconds.The device failed the test and arced through the pencil handle.The root cause according to the supplier was an issue with the parameters of the ultrasonic welding machine not being adequate and caused a failure of the test.A corrective action is being taken by the supplier to review the current utrasonic welding parameters and validation and making the updates necessary.The next three months of inspection records will be collected after the corrective actions are completed.The complaint rate is low with the only additional complaint being from the same customer.Based on the investigation, this can be seen as the final report.If additional information is obtained that alleges any additional patient involvement or need for additional 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: 15042791
• Report Number: 3007208013-2022-00028
• Device Sequence Number: 17886733
• 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
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 08/16/2022

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: 09/03/2024
• Device Model Number: SCH10
• Device Catalogue Number: SCH10
• Device Lot Number: 210806030
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/24/2022
• Supplement Date Received by Manufacturer: 08/09/2022
• Initial Report FDA Received Date: 07/18/2022
• Supplement Report FDA Received Date: 08/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/03/2021
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown