MAUDE Adverse Event Report: ARTHREX, INC. APOLLO RF 50°; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	APOLLO RF 50°
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/08/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
Event or Problem Description
On 08/08/2022, it was reported by a sales representative via sems that an ar-9800 synergyrf¿ console and an ar-9815 apollo rf 50° had an issue.The handpiece probe tip was sparking inside the patient.This was discovered during use with no impact to the patient.Additional information has been requested.On 08/24/2022, the sales representative replied via email and stated the following: the issue was apparently with the rf apollo tip and not the unit.That was working fine.They just changed the apollo rf probe, and the surgery (unspecified procedure) continued without incident.The surgeon mentioned that there was no harm related to it, and the surgery was finished with another rf apollo probe and the same console unit.The probe was available for return.

• Brand Name: APOLLO RF 50°
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: vik bajnath ; 8009337001
• MDR Report Key: 15310911
• Report Number: 1220246-2022-05430
• Device Sequence Number: 20200391
• Product Code: GEI
• UDI-Device Identifier: 00888867142527
• UDI-Public: 00888867142527
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K161581
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 08/29/2022

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 Model Number: APOLLO RF 50°
• Device Catalogue Number: AR-9815
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2022
• Initial Report FDA Received Date: 08/29/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown