STRYKER INSTRUMENTS-KALAMAZOO SYSTEM 7 DUAL TRIGGER ROTARY; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
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Catalog Number 7205000000 |
Device Problem
Unintended Power Up (1162)
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Patient Problem
No Patient Involvement (2645)
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Event Date 07/08/2016 |
Event Type
malfunction
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Event Description
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It was reported that during testing at the manufacturer facility, the handpiece had run-on.No patient involvement, no delay, no medical intervention and no adverse consequences were reported with this event.
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Manufacturer Narrative
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The reported event was duplicated.A service technician functionally evaluated the device and found that the trigger would stick in the reverse position causing run-on.The service technician found contamination on the trigger assembly.Preventative maintenance was performed.Based on a review of risk documentation, contaminates can cause run-on in the trigger area.The event did not involve a product problem indicating a non-conformity or unanticipated hazard.No further action is required at this time.
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Event Description
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It was reported that during testing at the manufacturer facility, the handpiece had run-on.No patient involvement, no delay, no medical intervention and no adverse consequences were reported with this event.
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Search Alerts/Recalls
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