Model Number URF-P7 |
Device Problem
Erratic or Intermittent Display (1182)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 02/21/2020 |
Event Type
malfunction
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Manufacturer Narrative
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The subject device was not returned to olympus medical systems corp.(omsc), but returned to olympus (b)(4).Olympus polska evaluated the subject device and could confirm the reported phenomenon.Olympus polska also confirmed the cementing defect of the bending section.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 the retrograde intrarenal surgery (rirs), the endoscopic image was blurred.The user continued to use the subject device and completed the procedure.There were no reports of patient injuries related to this incident.
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Manufacturer Narrative
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This supplemental report is being submitted to provide additional information.The subject device was not returned to olympus medical systems corp.(omsc), therefore omsc cannot investigate the subject device.Omsc reviewed the manufacturing history (dhr) of the subject device and confirmed no irregularity.The exact cause of the reported event could not be conclusively determined.If additional information becomes available, this report will be supplemented.
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Search Alerts/Recalls
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