Catalog Number 5100060001 |
Device Problem
Failure to Auto Stop (2938)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 11/27/2014 |
Event Type
malfunction
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Event Description
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It was reported that the perforator bit did not stop during a craniotomy.It was further reported that the procedure was completed successfully and there was no patient impact, adverse consequences or surgical delay reported as a result of this event.The rep stated that the perforator bit did not stop during the craniotomy.It was further reported that the surgeon made 8 bur holes around the circumference of the skull and was seen to be rocking the drill.
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Manufacturer Narrative
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The device was not returned to the manufacturer.
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Event Description
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It was reported that the perforator bit did not stop during a craniotomy.It was further reported that the procedure was completed successfully and there was no patient impact, adverse consequences or surgical delay reported as a result of this event.
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Manufacturer Narrative
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The device is available for return.A follow up report will be filed once the quality investigation is complete.Device not yet returned to the manufacturer.
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Event Description
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It was reported that the perforator bit did not stop during a craniotomy.It was further reported that the procedure was completed successfully and there was no patient impact, adverse consequences or surgical delay reported as a result of this event.The rep stated that the perforator bit did not stop during the craniotomy.It was further reported that the surgeon made 8 bur holes around the circumference of the skull and was seen to be rocking the drill.
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Manufacturer Narrative
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The customer reported the burring technique as "rocking" the drill.The ifu for this device warns "do not rock or bind the perforator during use.Failure to comply may result in serious patient injury or death." the quality investigation is complete.Device not returned.
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Search Alerts/Recalls
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