Catalog Number 5100060001 |
Device Problem
Failure to Auto Stop (2938)
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Patient Problems
Abrasion (1689); Sinus Perforation (2277)
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Event Date 04/05/2019 |
Event Type
Injury
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Manufacturer Narrative
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A follow up report will be filed once the quality investigation is complete.
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Event Description
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It was reported that during a cranial procedure, the perforator bit did not stop.It was also reported that there was an unintentional durotomy including perforation of brain tissue gray matter during a bur hole as a result of this event.It was further reported that perforation of the transverse sinus occurred.It was also reported the surgeon had to stop the cranial bleeding.It was further reported that there was a surgical delay.No further information was provided.
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Manufacturer Narrative
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The perforator product reported involved with this event was returned for evaluation and the disengagement mechanism within the perforator was tested and functioned as intended.The reported failure of failure to disengage could not be confirmed.The ifu #5100-060-700 rev.F provides instructions on how to test the disengagement function of the perforator prior to use.The ifu also warns: use extreme caution when drilling in conditions such as: bone that may vary in consistency and/or thickness greater than 1 mm.Adherent dura.High intracranial pressure.Other abnormalities in the area of penetration.The perforator may cut or nick the dura or brain.The ifu also contains the following warning; "caution should be taken to avoid use in skulls/skull areas that have thin bone (e.G.Temporal and suboccipital areas).Failure to comply may result in serious patient injury or death.".
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Event Description
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It was reported that during a cranial procedure, the perforator bit did not stop.It was also reported that there was an unintentional durotomy including perforation of brain tissue gray matter during a bur hole as a result of this event.It was further reported that perforation of the transverse sinus occurred.It was also reported the surgeon had to stop the cranial bleeding.It was further reported that there was a surgical delay.No further information was provided.
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Search Alerts/Recalls
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