MAUDE Adverse Event Report: YOUNG O/S LLC SPARTAN USA

Model Number J-3

Device Problems Inappropriate/Inadequate Shock/Stimulation (1574); Device Operates Differently Than Expected (2913)

Patient Problems Shock (2072); No Consequences Or Impact To Patient (2199)

Event Date 10/01/2015

Event Type  malfunction  

Manufacturer Narrative

The date of event is not correct.It was the end of (b)(6).Pma 510(k): this unit is around 13 yrs old.Young dental bought the company in 2003 and then obtura bought it in 2010.We can't find old manufacturer information before 2003.Mfg date: since this unit is really old, we don't have device manufacture date.Unit came in with a damaged power cord and foot pedal.The cables look like they were cut apart and spliced into something else.The hand piece shell has been over tightened so much that it now is covering the metal ring that would normally sperate the bottom shell and the top shell of the hand piece.The unit was tested on the lowest possible frequency setting, but instead of using it to cut silky rock, i put the tip up against one of the tip wrenches (metal), and i saw visible electrical "sparks" coming from the tip to the tip wrench; this does not occur normally.

Event Description

Patient felt slight shock, pulled away from doctor, she questioned him/her about it and they said it felt funny.She tried the unit on her finger tip and felt the slight shock herself.Stopped using the unit and contacted her sales rep.Could not remember any info about who the patient was, and there were no side effects from the shock.

• Brand Name: SPARTAN USA
• Manufacturer (Section D): YOUNG O/S LLC; algonquin IL
• Manufacturer Contact: asmita patel ; 2260 wendt st.; algonquin, IL 60102 ; 8474585642
• MDR Report Key: 5229082
• MDR Text Key: 31500026
• Report Number: 1926480-2015-00001
• Device Sequence Number: 1
• Product Code: ELC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: J-3
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/21/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/16/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Outcome(s): Required Intervention