Catalog Number 5100060001 |
Device Problem
Failure to Auto Stop (2938)
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Patient Problem
Abrasion (1689)
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Event Date 04/26/2019 |
Event Type
Injury
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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.It was reported in this event that the patient exhibited an adherent dura.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 continued to drill beyond expected time and perforated the dura.It was further reported that the dura was repaired by a surgical technique.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.It was reported in this event that the patient exhibited an adherent dura.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 continued to drill beyond expected time and perforated the dura.It was further reported that the dura was repaired by a surgical technique.No further information was provided.
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Search Alerts/Recalls
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