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

Model Number APOLLO RF 90° MULTIPORT

Device Problems Break (1069); Defective Device (2588)

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

Event Date 01/13/2022

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.If the device becomes available for evaluation, a follow-up report will be submitted.

Event Description

It was reported that during a knee arthroscopy surgery a deflagration occurred in the joint.The device ar-9811 (lot 2101252) is defect and the device ar-3350-4031 (sn:(b)(4)) was also damaged and is defect.It is unclear, if the error was caused by the probe ar-9811 or the console ar-9800 (sn:(b)(4)).No part of the devices broke off.According to the surgeon no harm for patient, operator or third party occurred.The surgery was finished successfully with a different device.It was not necessary to switch the surgical technique or do a second surgery.

Manufacturer Narrative

Complaint confirmed.Visual evaluation showed damaged to the electrode face and ceramic, at the left bottom.This damaged aligns also with the damaged observed on the distal tip of the returned scope.Also the electrode face has signs of usage and bend shaft.Device memory was check and no error message was found.No functional testing was perform due to the as received damaged of the device.Likely causes are by hitting the device with another device during use and prying/leveraging forces to the device during use.

• 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
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: vik bajnath ; 8009337001
• MDR Report Key: 13397234
• MDR Text Key: 284870727
• Report Number: 1220246-2022-04361
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00888867248243
• UDI-Public: 00888867248243
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K161581
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 05/19/2022

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?: No
• Device Operator: Health Professional
• Device Model Number: APOLLO RF 90° MULTIPORT
• Device Catalogue Number: AR-9811
• Device Lot Number: 2101252
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 01/13/2022
• Initial Date FDA Received: 01/31/2022
• Supplement Dates Manufacturer Received: 01/13/2022
• Supplement Dates FDA Received: 05/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other