Model Number TJF-150 |
Device Problem
Break (1069)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 10/26/2020 |
Event Type
malfunction
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Manufacturer Narrative
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The subject device 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 is received, this report will be supplemented.
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Event Description
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Olympus medical systems corp.(omsc) was informed that during the incoming inspection for repair at the service department of olympus medical systems india (omsi), it was found that there was a crack and gap on the distal end cover.There was no report of patient injury associated with this event.
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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.Omsc reviewed the manufacture history (dhr) of the subject device and confirmed no irregularity.The exact cause of the reported phenomenon could not be conclusively determined.However, based upon the past similar cases, there was the possibility that the reported phenomenon was attributed to the following causes.-physical stress was applied to the distal end of the endoscope due to the user handling for unspecified reason.
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Search Alerts/Recalls
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