Model Number CLK-4 |
Device Problem
Failure to Power Up (1476)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Manufacturer Narrative
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The device has not yet been returned for evaluation.However, the customer did note that the unit had been physically damaged and requested replacement parts.Olympus technical assistance center (tac) personnel informed the customer that we do not provide replacement components for that section of the device.Tac went on to recommend the device be returned for repair.If additional information becomes prior to the conclusion of the investigation, a supplemental report will be filed.
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Event Description
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As reported, the halogen light source device would not turn on.According to the initial reporter, the device also has some physical damage on the outside of the unit.There was no patient harm or consequence reported as a result of this event.
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Manufacturer Narrative
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This supplemental report is being submitted to provide the results of the manufacturer¿s investigation.A review of the instructions for use (ifu) was conducted during this investigation.The ifu contains the following statements: ¿do not use a pointed or hard object to press the switches on the front panel.This may break the switches.To avoid breaking electric contacts and causing a malfunction: do not subject any connector to undue force.¿ the root cause could not be determined.Probable causes include: a failure of the power supply unit, the switch, or a failure of the main board.Additionally, it is possible that the unit failed due to age deterioration over long-term repeated use.Olympus will continue to monitor the field performance of this device.
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Search Alerts/Recalls
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