Model Number TJF-150 |
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 (b)(4).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 (b)(4) on (b)(6) 2021, it was found that inside of the light guide lens was dirty and the foreign material adhered to 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 inside of the light guide lens was dirty due to the following cause.- the moisture entered the subject device and components inside the light guide lens lens got corroded and the corrosion product may have remained under the light guide lens lens as dirt.Omsc surmised that the foreign material adhered to the forceps elevator of the subject device due to the following causes.- since reprocessing by the user was insufficient, the foreign material was not removed.- process of reprocessing conducted by the user was different from the process recommended in the instruction manual of the subject device.
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Search Alerts/Recalls
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