Model Number URF-P6R |
Device Problem
Break (1069)
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Patient Problem
No Code Available (3191)
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Event Date 05/20/2020 |
Event Type
Injury
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Manufacturer Narrative
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The subject device in this report has not been returned to olympus medical systems corp.(omsc) for evaluation.The exact cause of the reported event could not be conclusively determined at this time.If additional information becomes available, this report will be supplemented.
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Event Description
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During retrograde intrarenal surgery (rirs), a stone got stuck between the ureter and the subject device.When the user tried to withdraw the subject device, the bending section rubber was ruptured and scratched.The patient was not injured but under observation.However, there was a possibility that the patient has experienced pain or discomfort.
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Manufacturer Narrative
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This supplemental report is being submitted to provide additional information.Olympus medical systems corp.(omsc) investigated the device and found that there ware many scratches at the bending section rubber.Omsc surmised that a stone got stuck between the device and ureter might have damaged the bending section rubber when the physician was removing the device from the patient.The device history record indicates that the subject device has been shipped in conformity to the specifications.There were no further details provided.If significant additional information is received, this report will be supplemented.
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Search Alerts/Recalls
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