Model Number GF-UCT180 |
Device Problem
Device Contamination with Chemical or Other Material (2944)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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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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Event Description
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Olympus medical systems corp.(omsc) was informed that during the evaluation at olympus (b)(4) on (b)(6) 2021, it was found that the foreign material adhered to the distal end of the backside of the forceps elevator of the subject device.Other detailed information was not provided.There was no reported of patient injury associated with the event.
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Manufacturer Narrative
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This supplemental report is being submitted to provide additional information.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 of this event could not be conclusively determined.Olympus medical systems corp.(omsc) surmised that the reported phenomenon occurred after the start of use.
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Search Alerts/Recalls
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