It was reported that during preparation for use for a lithotripsy procedure, the device exhibited error, probe error message illuminated in red on error, and probe error buttons.User tried two different handpiece however, the issue was not resolved.The intended procedure was completed by using a laser device.The serial number on the device used was not provided.No patient harm, or injury reported due to the event.No user injury reported.
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This supplemental report is being submitted to provide review of the device history records (dhr), unique device identifier (udi) number, device evaluation and investigation conclusion.The device was returned to olympus uk (united kingdom).Evaluation of the device, the reported issue was confirmed as the unit was found not to produce output due to faulty transducer receptacle.One leg with its screw was also missing.Device history records were reviewed and showed the product met all specifications upon release.The reported failure is a known phenomenon and is produced as a result of damage to the transducer receptacle.Damage to the 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 on the ifu (instruction for use) the user manual states: 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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