Model Number URF-P7 |
Device Problem
Break (1069)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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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 olympus local service department on may 25, 2021, it was found that the coating of the insertion tube of the subject device had been partially peeled off.Other detailed information was not provided.There was no report of patient injury associated with the event.This device is an olympus asset.
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Manufacturer Narrative
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The subject device was returned to the olympus local service department.A supplemental report will be submitted, if additional or significant information becomes available at a later time.
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Manufacturer Narrative
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This supplemental report is being submitted to provide additional information.Omsc was informed user information following.San joan hospital center s.I.E.Inst.Equipamentos portugal 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.Olympus medical systems corp.(omsc) was informed that the insertion tube of the subject device was scratched.Omsc surmised that the reported phenomenon occurred due to physical stress and other on the insertion tube due to the user handling and other.
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Search Alerts/Recalls
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