MAUDE Adverse Event Report: ARTHREX, INC. APOLLO RF 90° MULTIPORT; ELECTROSURG CUT/COAG DEVICE

Model Number APOLLO RF 90° MULTIPORT

Device Problem Defective Device (2588)

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

Event Date 06/08/2023

Event Type  malfunction  

Manufacturer Narrative

The contribution of the device to the reported event has not yet been determined as the device has not been returned for evaluation at this time.A follow-up report will be submitted, including a most likely cause if a root cause can not be determined.

Event Description

It was reported that during a shoulder arthroscopy two devices failed.There was no harm for patient, operator or third party reported.The surgery was finished successfully with a new device from another manufacturer.It was not necessary to switch the surgical technique or do a second surgery.15-jun-2023 update dw further information were provided that the console did not showed any error message.It was further reported that it makes the expected noise and and the display everything appeared to be normal but the devices did not work.

Manufacturer Narrative

The complaint allegation was confirmed.Two unpackaged ar-9811 serial/batch number (b)(6) were received for investigation.The devices were tested with saline water.The testing console recognized the devices and when the buttons were pressed, an audible signal was emitted, but the devices did not ablate.The returned devices were visually inspected, and a polymer-like substance was noted in the probe face holes of one device.The cause for the devices not ablating is associated with a supplier manufacturing process and the investigation has been documented on ncr-22163.The cause for the substance in the face holes has not been confirmed, but a probable cause could be attributed to a supplier manufacturing issue.Additional investigation will be performed, and an ncr will be initiated if appropriate.

• Brand Name: APOLLO RF 90° MULTIPORT
• Type of Device: ELECTROSURG CUT/COAG DEVICE
• 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: emily shafer ; 8009337001
• MDR Report Key: 17272868
• MDR Text Key: 318657749
• Report Number: 1220246-2023-07077
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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: 10/06/2023

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
• Device Operator: Health Professional
• Device Model Number: APOLLO RF 90° MULTIPORT
• Device Catalogue Number: AR-9811
• Device Lot Number: 68332526
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 06/09/2023
• Initial Date FDA Received: 07/06/2023
• Supplement Dates Manufacturer Received: 06/09/2023
• Supplement Dates FDA Received: 10/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1