MAUDE Adverse Event Report: BOVIE MEDICAL MCKESSON; ELECTROSURGICAL ROCKER PENCIL W/HOLSTER

Model Number	22-ESP1H
Health Effect - Clinical Code	Superficial (First Degree) Burn (2685)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device has not yet been made available from the user for evaluation.Limited information has been made available at this time.We will continue to follow up with the user for additional information.A follow up report will be submitted once additional information is received.
Event or Problem Description
Customer alleged the product "sparked and lit up and caused some minor burns on a patient.".
Additional Manufacturer Narrative
At this time, the device was not made available for evaluation and limited information has been provided.After repeated attempts to contact the reporter for additional information and to request the return of the device, no response has been received.The reporter is not responding to our requests.Based on this information, this can been seen as the final report.If additional information is received that alleges additional patient involvement or need for corrective actions, a follow up report will be submitted.

• Brand Name: MCKESSON
• Common Device Name: ELECTROSURGICAL ROCKER PENCIL W/HOLSTER
• Manufacturer (Section D): BOVIE MEDICAL; 5115 ulmerton road; clearwater FL 33760
• MDR Report Key: 11558086
• Report Number: 3007208013-2021-00013
• Device Sequence Number: 17006684
• Product Code: GEI
• UDI-Device Identifier: 20612479209132
• UDI-Public: 20612479209132
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K936304
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/23/2021

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 Model Number: 22-ESP1H
• Device Catalogue Number: 22-ESP6H
• Initial Date Received by Manufacturer: 03/01/2022
• Supplement Date Received by Manufacturer: 03/01/2022
• Initial Report FDA Received Date: 03/23/2021
• Supplement Report FDA Received Date: 04/01/2021
• Patient Sequence Number: 1