It was reported that the device transducer receptor malfunctioned.The issue found during incoming inspection.According to the reporter, the device when press switch on transducer handling ,¿high mode/standard mode¿ had switched.There was no patient involvement on this report, no user harm or injury reported due to the event.
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This supplemental report is being submitted to provide review of the device history records (dhr), unique device identifier (udi) number and investigation conclusion.Please see updated sections: d4,d10,g4, g7, h2, h3,h4, h6 and h10.The device was evaluated by olympus thailand.The user report was confirmed.It was found that transducer receptacle damage resulted in the reported phenomenon.Device history records were reviewed and showed the product met all specifications upon release.Damage to the transducer receptacle is often incurred as a result of user error, often the user does not realize all connections are push/pull and instead the plug is twisted upon connection or removal.This action results in damage to the pins internal to the socket and may crack or damage the housing.As stated in the instruction for use: connect the transducer to the generator by pressing the plug straight in.Caution do not twist or turn the plug.Connect the transducer to the generator by aligning the key way of the transducer connector with the key way slot on the transducer receptacle on the front panel.Push straight in.Caution do not twist or turn the plug.Olympus will continue to monitor complaints for this device.
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