Catalog Number 261221 |
Device Problem
Fail-Safe Did Not Operate (4046)
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Patient Problems
Brain Injury (2219); No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
Injury
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Manufacturer Narrative
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An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.
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Event Description
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A physician reported disengagement failure of a perforator (b)(4) during surgery causing dural damage.The dura was reconstructed.According to information provided, the manufacturer of the drill is midas and it is unknown whether it was electric or pneumatic.It was also unknown if the perforator clicked in place in the drill.The recommended spring test were performed between each burr hole, and angle of approach was perpendicular as the ifu states.It is unknown if the perpendicular approach was maintained through the drilling process or a rocking motion included.It is unknown if there was constant downward pressure.
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Manufacturer Narrative
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Additional information received: brain contusion was also observed.
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Event Description
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N/a.
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Manufacturer Narrative
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Perforator (id: 261221) has been returned for evaluation.Unique device identification (udi): (b)(4).Failure analysis - a visual inspection utilizing unaided eye and noted that the unit has significant tooling on the od and was potentially autoclaved.Spring test was performed and the unit passed the spring test and functioned as designed.A functional test was performed, the unit drilled 5 holes with no issues and functioned as designed.Therefore, the complaint condition could not be verified.Root cause - root cause remains undetermined.Product was received for analysis and the analyst could not confirm the complaint condition.Possible root cause per the failure analyst ¿user misuse or drill allows to be set incorrectly.
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Search Alerts/Recalls
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