Model Number URF-V2 |
Device Problem
Break (1069)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Type
malfunction
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Manufacturer Narrative
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The 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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The angulation of the device became locked.The user could move the angulation control lever.However, the user could not straighten the bending section of the device.There was no report of patient injury associated with this event.The user facility did not provide other detailed information.
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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) for evaluation, but was returned to olympus europa k.G (oekg).Omsc reviewed the manufacturing history (dhr) of the subject device and confirmed no irregularity.Based upon the information from oekg there was the possibility that the reported phenomenon was attributed to the following occurrence mechanisms.The angulation wire cannot move forward or backward, because the pitch of the coil pipe through which the angulation wire slides shifts (deforms).The exact cause of the shifting (deformation) could not be conclusively determined.However, there was the possibility that the shifting (deformation) was attributed to the excessive stress added to the angulation wire.
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Search Alerts/Recalls
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