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
Smoking (1585)
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Patient Problem
No Patient Involvement (2645)
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Event Date 03/04/2015 |
Event Type
malfunction
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Event Description
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It was reported during service at manufacturer facility that the device is smoking.This event occurred during service therefore, 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, handpiece started smoking, was duplicated.Upon disassembly, a non-stryker motor and asic motor controller were found.All non-conforming parts were replaced along with other suggested components and the device was returned to the customer after passing the final inspection.
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Event Description
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It was reported during service at manufacturer facility that the device is smoking.This event occurred during service therefore, 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.Failure analysis is ongoing.
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Search Alerts/Recalls
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