MAUDE Adverse Event Report: ARTHREX, INC. APOLLO RF 90 MULTIPORT; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number APOLLO RF 90° MULTIPORT

Device Problems Break (1069); Crack (1135); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/22/2021

Event Type  malfunction  

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.

Event Description

It was reported that the electrode burned down and cracked inside.No harm or adverse event for patient, operator or third party was reported.The surgery was finished successfully with a new device with the same part number.It was not necessary to switch the surgical technique or do a second surgery.***update swit 27-jan-2021: the ar-9811 didn´t come in contact with patient.According to customer something was broken inside the ar-9811, that's why it burned down.

Manufacturer Narrative

Visual evaluation revealed that the ceramic encasing the probe tip was chipped at the top of the face of the ablator.Abrasion marks at the back of the device and charring was also noted along the remaining ceramic and face of the device.This event is most likely caused by prying/leveraging of the device against bone/bony tissue, and use of the device for extended periods of time.

• Brand Name: APOLLO RF 90 MULTIPORT
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 11275687
• MDR Text Key: 246839002
• Report Number: 1220246-2021-02544
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00888867248243
• UDI-Public: 00888867248243
• Combination Product (y/n): N
• PMA/PMN Number: K161581
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/22/2021

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 Operator: Health Professional
• Device Model Number: APOLLO RF 90° MULTIPORT
• Device Catalogue Number: AR-9811
• Device Lot Number: 2003215
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 01/22/2021
• Initial Date FDA Received: 02/03/2021
• Supplement Dates Manufacturer Received: 01/22/2021
• Supplement Dates FDA Received: 04/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other