MAUDE Adverse Event Report: YOUNG OS, LLC OBTURA HANDPIECE, NEW MAX

Model Number 823-810

Device Problems Overheating of Device (1437); Device Operates Differently Than Expected (2913); Temperature Problem (3022)

Patient Problem No Patient Involvement (2645)

Event Date 05/17/2017

Event Type  malfunction  

Event Description

Product base unit read error message 01 on (b)(6) 2017.User turned on unit (b)(6) 2017 and noticed burning smell.Base showed temperature of 250 degrees celsius and thermal protector on unit handpiece was melting.Device returned 2017-06-07 and preliminary investigation performed.Unit was turned on and showed signs of overheating.Handpiece was attached to new base unit and was still overheating.Test handpiece cable was attached to the unit and device heated normally.Investigation shows that handpiece cable malfunction may be causing overheat.

Manufacturer Narrative

Secondary investigation 16-jun-2017 a secondary investigation was completed in-house of the cable assembly of the unit which is a part purchased from supplier freeman manufacturing.One piece of internal wiring (referred to as the live wire) was found to be short, causing continuous strain which resulted in damage to the plastic pin connector and loss of secure cable connection to the unit.This error was not captured by the base unit with an error code.The investigation team contacted supplier update systems inc.To request that testing be done of unit's primary circuit board connectivity with the cable.The damaged cable, a drawing of the internal wiring, and a complete working unit was provided for testing of failure modes.As told by the supplier, the cable was modified on the unit by adding a toggle switch in the live wire to simulate disconnection at will.Root cause: 16-jun-2017 investigation showed that the presence of this short wire along with the damaged pin connector caused the live wire to lose contact with the base unit.The root cause of the short wire is a manufacturing defect.30-jun-2017 supplier update systems inc.Found that the heater continued to run in spite of the loss of communications from the hand piece.The root cause is faulty detection of loss of communications.Corrective actions: notification of the live wire manufacturing defect will be sent to supplier freeman manufacturing to implement corrective and preventive actions for the current wire and future cable production.Supplier update systems inc.Has a mechanism to detect a loss of communications between the cable and circuit board, which would disable the heater when this happens.They will be contacted to modify the device pcb function and codes to include this feature.

• Brand Name: OBTURA HANDPIECE, NEW MAX
• Type of Device: OBTURA HANDPIECE, NEW MAX
• 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 60102 ; 8474548542
• MDR Report Key: 6648640
• MDR Text Key: 77831254
• Report Number: 1926480-2017-00001
• Device Sequence Number: 1
• Product Code: EKR
• Combination Product (y/n): N
• PMA/PMN Number: K042828
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• 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: 06/16/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 823-810
• Device Catalogue Number: 823-810
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2017
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/18/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/27/2017
• 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