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Model Number CW-USLSA |
Device Problem
Output Problem (3005)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/24/2021 |
Event Type
malfunction
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Manufacturer Narrative
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During a call with tac (technical center assistance) engineer support, the customer olympus representative was unable to provide tac with any error code information.The representative confirmed that the customer is trying out another active cord.Tac informed the representative that if the active cord does not correct the fault error, the cyberwand unit will have to be sent in to olympus national service center for evaluation and repair.The subject device has not yet been received for evaluation.The cause of the issue cannot be determined at this time.Investigation is ongoing.This report will be supplemented accordingly following investigation.
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Event Description
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As reported, when the customer attempted to activate the handpiece in the cyberwand system, a fault error would occur after tuning the handpiece.Customer swapped out the handpiece but the same fault error occurred.There is no patient involvement reported on this event.No user injury reported.
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Manufacturer Narrative
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This report is being supplemented to provide additional information based on customer response and updates.The following sections were updated: e1, e2, e3, g3, g6, h2, h6 and h10.Further communication, the customer representative conveyed the following information : handpiece has just reached end of life or needs repair is what we have decided.No customer or patient injury or death.All is well - we just opened a different handpiece and things proceeded smoothly.Device is not returning for evaluation.No further information provided.
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Search Alerts/Recalls
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