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

Model Number APOLLO RF 90° MULTIPORT

Device Problems Break (1069); Detachment of Device or Device Component (2907); Intermittent Energy Output (4025)

Patient Problems Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/18/2022

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 on (b)(6) 2022 by a sales representative via sems that an ar-9811 ablator tip popped off, and another ablator was not responding.Case involvement, device broke during use."the ablator metal tip popped off the top of the ablator within the shoulder of the patient.There was a wire hanging out of the main ablator handpiece as well.They had just opened and was putting in the shoulder for the first time when this happened.They then opened a 2nd handpiece that also was not working for them.They put in the shoulder and the ablator would go in and out of working every few seconds and did not have a consistent pace of ablating.We tried troubleshooting but it was no help as it never ended up working.Opened up a third ablator and that worked fine.".

Manufacturer Narrative

Complaint confirmed.Two unpackaged ar-9811 batch numbers, 66507159, were received for investigation.Functional testing (only one device) with synergy rf found that after the device memory cleared, the device was not responding.Visual evaluation of both devices found that one of the device's aspirating probe faces was detached.

• 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: 15914509
• MDR Text Key: 307787150
• Report Number: 1220246-2022-05868
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00888867248243
• UDI-Public: 00888867248243
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161581
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 03/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2022
• Is this an Adverse Event Report?: No
• 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: 66507159
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/30/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1