Catalog Number 0406900000 |
Device Problem
Device Inoperable (1663)
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Patient Problem
Therapeutic Effects, Unexpected (2099)
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Event Date 02/12/2014 |
Event Type
malfunction
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Event Description
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It was reported that during a procedure the multigene radiofrequency generator would not turn on at all.It was reported that procedure had to be canceled.The user facility was unable to confirm whether or not the patient received anesthesia prior to the procedure being canceled.No medical intervention was reported with this event.
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Event Description
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It was reported that during a procedure the multigen radiofrequency generator would not turn on at all.It was reported that procedure had to be canceled.The user facility was unable to confirm whether or not the patient received anesthesia prior to the procedure being canceled.No medical intervention was 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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Manufacturer Narrative
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The contract manufacturer was not able to confirm the reported event.No repair was required and the device was returned to the user facility.
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Search Alerts/Recalls
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