Catalog Number 5100060001 |
Device Problem
Failure to Auto Stop (2938)
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Patient Problem
Abrasion (1689)
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Event Date 07/01/2019 |
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.Device discarded.
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Event Description
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It was reported that during a cranial procedure, the perforator bit did not stop and tore the dura.It was also reported that there was a few minutes delay to repair the dura.It was further reported that the procedure was completed successfully.
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Manufacturer Narrative
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The reported event, for perforator bit failure to disengage, was not confirmed as the perforator bit was not returned for evaluation.Without the perforator bit, the root cause cannot be determined.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.
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Event Description
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It was reported that during a cranial procedure, the perforator bit did not stop and tore the dura.It was also reported that there was a few minutes delay to repair the dura.It was further reported that the procedure was completed successfully.
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Search Alerts/Recalls
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