Model Number UM-G20-29R-3 |
Device Problems
Break (1069); Fluid/Blood Leak (1250)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/21/2021 |
Event Type
malfunction
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Manufacturer Narrative
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The subject device was returned to olympus medical systems corp.(omsc) for evaluation.Device history record review indicates that the product was manufactured and tested in accordance with all applicable procedures and met all final product release criteria.The exact cause was unknown; however, omsc assumed potential causes of the breakage of the distal tip were as follows.- the user forcibly insert or withdraw the device into the bending section of the endoscope with the bending section bent and it caused the failure.- during probe rotation, the user forcibly insert or withdraw the device into the endoscope and it caused the failure.
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Event Description
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Olympus medical systems corp.(omsc) was informed from the user that during preparation for use, an ultrasound image was faint.The user replaced the subject device with another device to complete the procedure.The device was returned to olympus medical systems corp.(omsc) for evaluation.Omsc found the distal tip of the device was broken and ultrasonic propagation fluid leaked out of the distal tip of the device.Other detailed information was not provided.There was no report of patient injury associated with the event.
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Search Alerts/Recalls
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