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Catalog Number 532.032 |
Device Problem
Device Stops Intermittently (1599)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 04/24/2014 |
Event Type
malfunction
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Event Description
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It was reported by (b)(6) that during an unspecified surgical procedure, it was observed that the battery casing device was functioning intermittently.There was a fourteen minute delay to the planned surgical procedure.A spare device was available for use.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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The actual device was returned for evaluation.(b)(4) evaluated the device and observed that the device ran intermittently.Therefore, the reported condition was confirmed.The assignable root cause was determined to be due to immersion during cleaning which is failure to follow directions for use.This was further defined as misuse, abuse and/or 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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