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Catalog Number 530.610 |
Device Problems
Device Emits Odor (1425); Smoking (1585); Temperature Problem (3022)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 06/24/2014 |
Event Type
malfunction
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Event Description
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It was reported that prior to surgery, it was observed that the battery oscillator device was heating up and started smoking.The reporter stated that it smelled like an electric fire.There were no delays to the planned surgical procedure as a spare device was available for use.There was no patient involvement reported.There were no reports of injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.
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Manufacturer Narrative
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As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Manufacturer Narrative
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Additional narrative: the actual device was returned for evaluation.Reliability engineering evaluated the device and observed that the wires on the electronic control unit (ecu) were corroded showing signs of damage.Therefore, the reported condition was confirmed.The assignable root cause was determined to be corrosion due to immersion during cleaning, which is failure to follow the directions for use and would be misuse / abuse and possibly user error.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Search Alerts/Recalls
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