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Model Number SPL-T |
Device Problem
Break (1069)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Manufacturer Narrative
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The asset device was returned to olympus.Upon inspection testing of the returned device, the suction port was broken off and was identified as non-repairable.There were no other defects noted.The device was returned unrepaired at in-house customer's request.The review of the device history record (dhr) did not find any abnormalities or anomalies identified during production.The device met all specifications upon release.The investigation determined the most likely cause of the failure as being handling of the device during reprocessing or during transit.The instructions for use (ifu) warns users on the proper handling of this device: ¿this product is a precision device; handle it with care.Avoid rough or violent handling, which may cause equipment damage." olympus will continue to monitor the field performance of this device.
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Event Description
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The olympus asset device, shockpulse lithotripsy transducer, was sent to the olympus service center.Upon inspection and testing of the returned device, it was discovered the suction port had broken off.There was not patient involvement.The medical device report (mdr) is being submitted to capture the reportable malfunction of the suction port broken off found during evaluation.
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Search Alerts/Recalls
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