Device was received and evaluated.Evaluation determined that the device was found with damaged receptacle unit, and pins were found bent.Minor scratches on the housing cover were observed.The identified parts were replaced, device was repaired.Once completed, the device was tested ,passed all required testing and specifications.The root cause of the issue was due to electronic component failure likely attributed to users handling issue and or maintenance.This mdr is being submitted retrospectively as part of a remediation effort related to the recent system, and process changes.A capa has been opened to manage the actions related to remediation of this issue and any required reporting.
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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.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) and as a preventive measure, 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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