Catalog Number 261221 |
Device Problem
Fail-Safe Did Not Operate (4046)
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Patient Problem
Brain Injury (2219)
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Event Date 10/03/2023 |
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 codman perforator while making the second burr hole at the tent (id (b)(6)).Dural damage and brain contusion were observed and hemostasis was performed.The event led to more than 30 minutes surgical delay.The patient¿s condition is stable.The manufacturer of the drill used with the perforator was anspach e-max.According to information provided, it is unknown if the drill was electric or pneumatic.It is also unknown if the perforator clicked in place in the drill and if the recommended spring tests were performed between each burr hole.Customer also informed that is unknown if the angle of approach was perpendicular as the ifu states.It is unknown if the perpendicular approach maintained through the drilling process or if there was any rocking motion included, and unknown if there was constant downward pressure.
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Manufacturer Narrative
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The codman perforator (id 261221) was returned for evaluation.Failure analysis - the perforator unit was inspected using the unaided eye.The unit was lightly soiled with organic material and had a completely worn eo label.The weld on the blue sleeve looked shallow.The unit was found to perform as intended and fulfilled the acceptance criteria.The unit did feel slightly ¿dull¿ when drilling, but disengagement failure could not be replicated.Root cause analysis ¿ the root cause is undetermined and was unable to be confirmed in the complaint evaluation.However, a potential cause of failure includes under misuse.
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Search Alerts/Recalls
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