MAUDE Adverse Event Report: BOVIE MEDICAL CORP. BOVIE MEDICAL; GROUNDING CABLE

Model Number	A1252C
Medical Device Problem Codes	Grounding Malfunction (1271); Output Problem (3005)
Health Effect - Clinical Code	Burn(s) (1757)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Awaiting return of the reported device and/or additional information from the complainint to complete the evaluation.
Event or Problem Description
The complainant alleges, "burned on the finger when using the a952 generator with a1252c cable.Cable did not ground correctly.No patient involvement.Physician involvement (minor burn)".
Additional Manufacturer Narrative
The nurse was having difficulty getting the a952 diathermy to work- an experienced sales person was face timing the customer to see what was happening and they were trouble shooting- the nurse went to pull the blade out of the handle and it sparked burning one of the fingers on her right hand.The unit was immediately picked up by our staff and a loan one was supplied.The machine was extensively tested by our biomedical dept and the conclusion was that the the nem alarm is not getting activated irrespective of whether a ground cable is connected or not.It is likely that the nurse accidentally activated the monopolar pencil thinking that the unit will not work as no ground cable was connected.The device is currently being sent back to the manufacturer.The root cause is determined to be unexpected component failure.If additional information is obtained that is pertinent to the investigation or provides additional details a follow-up report will be provided.Until such time, this can be seen as the final report.
Event or Problem Description
The complainant alleges, "burned on the finger when using the a952 generator with a1252c cable.Cable did not ground correctly.No patient involvement.Physician involvement (minor burn)".
Additional Manufacturer Narrative
The device was returned to the manufacturer for full investigation.The complaint was unable to be duplicated by the manufacturing team.The complaint was unable to be confirmed and true root cause remains undetermined.If additional information is obtained that is pertinent to the investigation or provides additional details a follow-up report will be provided.Until such time, this can be seen as the final report.
Event or Problem Description
The complainant alleges, "burned on the finger when using the a952 generator with a1252c cable.Cable did not ground correctly.No patient involvement.Physician involvement (minor burn)".

• Brand Name: BOVIE MEDICAL
• Common Device Name: GROUNDING CABLE
• 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: steven fox ; 3034 owen drive; antioch, TN 37013
• MDR Report Key: 19589129
• Report Number: 3007208013-2024-00028
• Device Sequence Number: 11591864
• Product Code: GEI
• UDI-Device Identifier: 10607151001541
• UDI-Public: 10607151001541
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K021817
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: A1252C
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/30/2024
• Supplement Date Received by Manufacturer: 05/30/2024; 05/30/2024
• Initial Report FDA Received Date: 06/21/2024
• Supplement Report FDA Received Date: 07/19/2024; 08/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Sex: Unknown