Catalog Number 5100060001 |
Device Problem
Failure to Auto Stop (2938)
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Patient Problem
Abrasion (1689)
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Event Date 02/28/2019 |
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 evaluated by mfr: awaiting return of device to manufacturer.
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Event Description
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It was reported that during a cranial procedure, the perforator continued to run on longer than expected.It was also reported that there was an unintentional dural opening and brain tissue damage as a result of this event.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 surgeon reported in this case that the patient exhibited an adherent dura and also the surgeon acknowledged he was using the stryker perforator bit in the temporal region of the patients skull.The device instructions for use (ifu) warns: use extreme caution when drilling in conditions such as: adherent dura, 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." the cause in this event is attributed to failure to follow instructions.
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Event Description
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It was reported that during a cranial procedure, the perforator continued to run on longer than expected.It was also reported that there was an unintentional dural opening and brain tissue damage as a result of this event.No further information was provided.
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Search Alerts/Recalls
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