Model Number CW-USLTA |
Device Problem
Electrical Power Problem (2925)
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Patient Problems
No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)
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Event Date 03/22/2020 |
Event Type
malfunction
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Manufacturer Narrative
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The suspect device was returned to olympus and evaluated for the user reported problem of "when you try to tune it, it makes no noise and gives a fault on the box." the user reported problem was confirmed and the cause assigned to broken wires inside the cord end to the transducer body, likely caused by user mishandling.
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Event Description
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The user facility reported to olympus that the device made no noise and "generated a fault on the box" when attempting to tune the device.No patient injury or harm was reported associated with the problem.The intended procedure is unknown.It is unknown if the procedure was completed.
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Manufacturer Narrative
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This supplemental report is being submitted to provide additional event information.
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Event Description
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The user facility provided additional event information: no patient injury associated with the reported problem occurred.The reported problem was found during equipment testing.
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Manufacturer Narrative
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This supplemental mdr is being submitted to provide the final results of the device evaluation and device history record (dhr) review.Updates to section h6.The failure was attributed to broken wires inside the cord to the transducer body.Damage to the wires is likely a result of general wear and tear.Review of the dhr determined that the device passed all visual inspection and functional testing.
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Search Alerts/Recalls
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