GYRUS ACMI, INC CW-USLTA CYBERWAND ADVANCED TRANSDUCER; LITHOTRIPTOR, ELECTRO-HYDRAULIC
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Model Number CW-USLTA |
Device Problems
No Device Output (1435); Failure to Power Up (1476)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/19/2021 |
Event Type
malfunction
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Event Description
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As reported, during preparation for use, the device would not work.Customer stated that they did the tuning, shut down the device and turned it on and would not work.Customer used another transducer and had no issues.There is no patient involvement associated on this reported event.No user injury reported.
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Manufacturer Narrative
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The subject device was not returned for evaluation.In a follow up communication with the customer, it was conveyed that the facility decided not to repair the device.There are no further information provided.The root cause of the reported issue cannot be determined as this time.Investigation is ongoing.This report will be supplemented following investigation.
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Manufacturer Narrative
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This report is being supplemented to provide additional information based on the legal manufacturer's investigation.The following sections were updated: g3, g6, h2, h6 and h10.As no device is returning to olympus, a device evaluation could not be performed.No findings are available.The observed failure is a known phenomenon that may likely have been a result of a lack of ensuring all connections and cables were proper prior to use.On page 4 of the device ifu (80862 rev ag), it states: "thoroughly inspect all electrical cables and probes before each use.Do not use if there is any evidence of deterioration.Replace if any damage or excessive wear is observed.Olympus will continue to monitor the field performance of this device.
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