Catalog Number E-FP_LL |
Device Problem
Degraded (1153)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 02/26/2016 |
Event Type
malfunction
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Manufacturer Narrative
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Additional narrative: 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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Event Description
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This is report 2 of 2 for the same event.It was reported that during pre-surgery testing it was observed that two foot control devices had exposed wires.It was reported that there was no delay to a planned surgical procedure as a third identical spare device was available to complete the procedure.There was no patient involvement reported.There were no patient or user injuries reported.It was reported there was no 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 reported event of the foot control - wires exposed during pre-surgery testing does not meet the criteria of a reportable complaint as it was not reported to have occurred during a surgical procedure and is unlikely to cause or contribute to serious injury.Therefore, the initial medwatch report was submitted in error.No further investigation will be performed at this time.
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Search Alerts/Recalls
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