Catalog Number 0406900000 |
Device Problem
Device Inoperable (1663)
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Patient Problem
Therapeutic Effects, Unexpected (2099)
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Event Date 04/01/2014 |
Event Type
malfunction
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Event Description
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It was reported that during a procedure at the user facility the touch screen of the multigen radiofrequency generator was not functioning.It was reported that "it looks like someone wiped down the screen and used too much cleaning agent, seeped in underneath the screen and there is a bubble under the screen".As a result, the procedure had to be canceled.It was reported that the patient had received "mac anesthesia" prior to the procedure being canceled.It was reported that the procedure was rescheduled and completed successfully.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 at the user facility, the touch screen of the multigen radiofrequency generator was not functioning.It was reported that "it looks like someone wiped down the screen and used too much cleaning agent, seeped in underneath the screen and there is a bubble under the screen." as a result, the procedure had to be canceled.It was reported that the patient had received "mac anesthesia" prior to the procedure being canceled.It was reported that the procedure was rescheduled and completed successfully.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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Upon visual inspection, the touch screen was found to be damaged.The device was repaired and returned to the user facility.
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Search Alerts/Recalls
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