Model Number SPL-T |
Device Problem
Defective Device (2588)
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Patient Problem
No Patient Involvement (2645)
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Event Type
malfunction
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Manufacturer Narrative
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Device was received and evaluated.Evaluation determined that the device failed to work with a spl-s generator when the l and h buttons were pressed, no energy output generated.The device cannot be repaired as olympus does not provide repair to this device.Customer was informed about the unrepaired device.A supplemental will be submitted if additional information becomes available following investigation.
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Event Description
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It was reported that the device power plug that plug into the tower was observed with what seems to be something plastic inside.There was no patient involvement on this event.No user injury reported.
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Manufacturer Narrative
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This supplemental report is to advise that upon further review this is not a reportable malfunction.Per the legal manufacturer, there is no potential for this issue to cause or contribute to death or serious injury if the malfunction were to recur.
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Search Alerts/Recalls
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