Model Number CW-USLSA |
Device Problem
Operating System Becomes Nonfunctional (2996)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 08/04/2020 |
Event Type
malfunction
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Manufacturer Narrative
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The device was not returned to olympus for evaluation.The cause of the reported event cannot be determined.If additional information becomes available at a later time, this report will be supplemented.
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Event Description
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It was reported that during a percutaneous nephrolithotomy, within 2 minutes of commencing the initial use of the instrument, the equipment failed as the fault led lit up on the console.Restarting the machine and changing the disposable tip did not fix the fault.The machine was non-operational from this time on.Per the customer, there was only one unit.As a result, the procedure was abandoned.The patient was under general anesthesia, and an incision had been made into the kidney.
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Manufacturer Narrative
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This report is being supplemented to provide additional information (d11, h10) regarding the reported event.Additional information received identified that per the customer, the device was visually inspected and passed the tuning process before being used on the patient.It was also reported the patient completed their treatment the following week.
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Manufacturer Narrative
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This supplemental report was submitted to provide additional information from the legal manufacturer for medical device report.The customer returned the referenced cw-uslsa cyberwand lithotripsy system.The evaluation of the confirmed system noted no defect or function deficiency with the generator but noted the returned transducer was non-functional.As the transducer was not returned to the manufacturer for further diagnostic testing a definitive root cause is no known.The transducer is non-serviceable, a replacement has been recommended (by oaz).This device was manufactured in december 2013 by cybersonics inc.Dhr records were provided to olympus for review and all records indicated that the product was manufactured according to all applicable procedures and met final product release criteria.No abnormalities were found.The investigation was completed by the legal manufacturer and determined that there is no manufacturing, material or processing related cause for this failure mode.Although the cause of the reported event is unknown, considering the age of the generator (manufactured in 2013) failure of the transducer may be a result of general wear and tear due to age.As stated on the ifu and as a preventive measure, the user manual states: the transducer is validated for 100 use cycles.Olympus will continue to monitor complaints for this device.
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Search Alerts/Recalls
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