Catalog Number 01 046 02 |
Device Problems
Incorrect Measurement (1383); Insufficient Information (3190)
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Patient Problems
Cerebrospinal Fluid Leakage (1772); Tissue Damage (2104)
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Event Date 08/30/2019 |
Event Type
Injury
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Event Description
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It was reported that during surgery, the surgeon unknowingly advanced the device past the skull base into the brain causing a cerebral spinal fluid (csf) leak.The surgeon had to create a soft tissue flap to repair the dura; the patient remained under observation for an additional day.
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Manufacturer Narrative
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Device evaluation: follow-up report submitted to document device evaluation results.
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Event Description
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It was reported that during surgery, the surgeon unknowingly advanced the device past the skull base into the brain causing a cerebral spinal fluid (csf) leak.The surgeon had to create a soft tissue flap to repair the dura; the patient remained under observation for an additional day.
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Search Alerts/Recalls
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