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

Model Number APOLLO RF 50°

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Insufficient Information (4580)

Event Date 09/15/2021

Event Type  malfunction  

Manufacturer Narrative

During returned device evaluation, a reportable malfunction was discovered.The complaint is confirmed.Device was received: ar-9815 batch 2009082, unpackaged.Functional testing was not performed due to the device's discovered reportable status.The observed burn marks at the distal tip suggest excessive ablation without proper fluid content, making it the most likely cause of the reported issue.

Event Description

It was reported that during a knee arthroscopy the device stopped working.No part of the device broke off.There was no harm or adverse event for patient, operator or third party 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.During returned device evaluation, a reportable malfunction was discovered.

• Brand Name: APOLLO RF 50°
• 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: 12853664
• MDR Text Key: 282278353
• Report Number: 1220246-2021-03982
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00888867142527
• UDI-Public: 00888867142527
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: K161581
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/22/2021

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 50°
• Device Catalogue Number: AR-9815
• Device Lot Number: 2009082
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/04/2021
• Initial Date FDA Received: 11/22/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1