Model Number NA-U200H-8022 |
Device Problem
Manufacturing, Packaging or Shipping Problem (2975)
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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 subject device was returned to olympus medical systems corp.(omsc).The exact cause has been under investigation.A supplemental report will be submitted, if additional or significant information becomes available at a later time.
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Event Description
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During inspection before use, the foreign object was found in the sterile package.The intended procedure was completed with another device.There was no patient injury reported.This is the report regarding the foreign object in the sealed sterile package.
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Manufacturer Narrative
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This is a supplemental report to provide additional information.The subject device was returned to olympus medical systems corp.(omsc) for evaluation.The sterile package was opened.A black foreign object which was not a component of the subject device was also returned.A foreign material adhered to the tip of the insertion part.The manufacturing record was reviewed and found no irregularities.The root cause could not be identified because the sterile package was opened and there were no problems with the manufacturing records.
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Search Alerts/Recalls
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