MAUDE Adverse Event Report: YOUNG OS, LLC PIEZO-ELECTRIC MTS 115V, OS - ALG; ULTRASONIC SCALER

Catalog Number 942-100

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

Patient Problem Shock (2072)

Event Date 11/30/2016

Event Type  malfunction  

Manufacturer Narrative

Customer mentioned that they will send the device back but we have not received yet.

Event Description

Obtura received a complaint saying that two technicians were shocked while preparing the unit for use.The unit was shocking the technicians when they plugged the hand piece cable from the unit into the hand piece.  the shock was not from the tip of the hand piece.  the technicians' that received the shock did not require medical treatment.

Manufacturer Narrative

Corrected serial number to (b)(4).On (b)(6) 2017 a functional test was performed using a rms multimeter to detect electrical arcing.An arc was seen from the end of the hand piece cable and from the end of the hand piece tip when connected to the sensor.To identify which piece was failing, the hand piece was tested with a different base unit cable.There were no signs of arcing in this case, so it was determined that the hand piece cable was causing the leakage current and this electrical arc coming from the cable/connector body may have been what shocked the user holding the hand piece.On (b)(6) 2017 the cable manufacturer was contacted for further investigation and they confirmed the part had a small amount of black wire that was exposed on the inside of the nut connector.This was causing the metal nut to occasionally come into contact with the wire at certain angles.The root cause was confirmed to be the defective cable on (b)(6) 2017.The manufacturer performs continuity testing when manufacturing this product, and informed us that an additional test will be added to the process in order to test the nut to ensure it is not making contact with the wires to prevent future recurrence.

• Brand Name: PIEZO-ELECTRIC MTS 115V, OS - ALG
• Type of Device: ULTRASONIC SCALER
• Manufacturer (Section D): YOUNG OS, LLC; 2260 wendt st; algonquin 60102
• Manufacturer (Section G): YOUNG OS, LLC; 2260 wendt st; algonquin 60102
• Manufacturer Contact: asmita patel ; 2260 wendt st; algonquin, IL 60102 ; 8474585642
• MDR Report Key: 6187294
• MDR Text Key: 62790418
• Report Number: 1926480-2016-00002
• Device Sequence Number: 1
• Product Code: ELC
• Combination Product (y/n): N
• PMA/PMN Number: K002521
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 07/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: 942-100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2017
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/30/2016
• 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): Other