Lot Number 160520H |
Device Problem
Insufficient Information (3190)
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Patient Problem
No Information (3190)
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Event Date 12/08/2015 |
Event Type
No Answer Provided
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Manufacturer Narrative
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The user facility stated that the chemical indicator present evidenced passing results.A steris service technician inspected the v-pro max and found the sterilizer to be operating properly.The technician reviewed the cycle print out subject of the reported event and no issues were noted; the technician returned the sterilizer to service.The biological indicator present during the time of the reported event was a steris bi.The dhr for the bi lot number was reviewed and no issues were noted.Steris performed in-service training on the proper use and operation of the sterilizer and biological indicator.
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Event Description
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The user facility reported that after a completed v-pro max sterilization cycle the biological indicator present did not evidence passing results.Instruments present were subsequently utilized in patient procedure(s).The user facility declined to provide information regarding their protocol of patient notification.
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Search Alerts/Recalls
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