Catalog Number 0406900000 |
Device Problem
Device Inoperable (1663)
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Patient Problem
Therapeutic Effects, Unexpected (2099)
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Event Date 02/26/2014 |
Event Type
malfunction
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Event Description
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It was reported that during set up for a procedure the multigen radiofrequency generator would turn on, but nothing would work.As a result, the procedure had to be canceled.It could not be confirmed whether or not the patient had received anesthesia prior to the procedure being canceled.No medical intervention and no adverse consequences were reported with this event.
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Manufacturer Narrative
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A follow up report will be filed after the quality investigation has been completed.
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Event Description
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It was reported that during set up for a procedure the multigen radiofrequency generator would turn on, but nothing would work.As a result, the procedure had to be canceled.It could not be confirmed whether or not the patient had received anesthesia prior to the procedure being canceled.No medical intervention and no adverse consequences were reported with this event.
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Manufacturer Narrative
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Upon visual inspection, the device was found to have a broken component on the rf amplifier.The device was also found to have a significant amount of physical damage.Based on the amount of physical damage, it appeared to have been dropped.The device was repaired and returned to the user facility.
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Search Alerts/Recalls
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