MAUDE Adverse Event Report: YOUNG OS, LLC OBTURA HANDPIECE, NEW MAX; PLUGGER, ROOT CANAL, ENDODONTIC

Model Number OBTURA III MAX

Device Problems Insufficient Heating (1287); Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Date 06/15/2016

Event Type  malfunction  

Event Description

When the technician was doing an investigation for the obtura iii max, it was noticed that the temperature continued to rise past the setting it was given.When set to 200 degrees celsius the display showed that the device was at a lower temperature and still trying to reach 200 but the temperature probe was showing the unit was continuing to rise in temperature, exceeding 300 degrees celsius.

• Brand Name: OBTURA HANDPIECE, NEW MAX
• Type of Device: PLUGGER, ROOT CANAL, ENDODONTIC
• Manufacturer (Section D): YOUNG OS, LLC; 2260 wendt st; algonquin IL 60102
• Manufacturer (Section G): YOUNG OS, LLC; 2260 wendt st; algonquin IL 60102
• Manufacturer Contact: asmita patel ; 2260 wendt st; algonquin, IL 60102 ; 8474585642
• MDR Report Key: 5809751
• MDR Text Key: 50077164
• Report Number: 1926480-2016-00001
• Device Sequence Number: 1
• Product Code: EKR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K042828
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Service and Testing Personnel
• Type of Report: Initial
• Report Date: 07/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: OBTURA III MAX
• Device Catalogue Number: 823-810
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/08/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/26/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1