STRYKER INSTRUMENTS-KALAMAZOO SYSTEM 5 SINGLE TRIGGER ROTARY HANDPIECE; INSTRUMENT, SURGICAL, ORTHOPEDIC, DC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
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Catalog Number 4203000000 |
Device Problem
Unintended Power Up (1162)
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Patient Problem
No Patient Involvement (2645)
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Event Date 03/17/2015 |
Event Type
malfunction
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Event Description
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It was reported during routine maintenance conducted by a manufacturer field service technician at the user facility that the drill is running without engaging trigger.No associated procedure, 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 device has been received, failure analysis is in progress; additional information will be submitted once the quality investigation is completed.
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Event Description
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It was reported during routine maintenance conducted by a manufacturer field service technician at the user facility that the drill is running without engaging trigger.No associated procedure, 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, drill is turning without engaging the trigger, was duplicated.Device was repaired and returned to customer after passing the final inspection.
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Search Alerts/Recalls
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