Model 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 05/10/2022 |
Event Type
Injury
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Event Description
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A physician reported disengagement failure of a codman disposable perforator (id 261221) causing dural damage and brain contusion during making the third burr hole at the tent.Hemostasis was performed.The drill used with the perforator was a midas (medtronic).According to the physician, bone thickness was flat, but there was a tendency for skull and dural adhesions.The patient underwent craniotomy because of impaired consciousness due to right subcortical hemorrhage.It is unknown if the drill was electric or pneumatic, or if the perforator clicked in place on the drill.It is also unknown if the recommended spring tests were performed between each burr hole.The patient is under follow-up with impaired consciousness and unilateral paralysis.
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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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N/a.
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Manufacturer Narrative
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The disposable perforator (id 261221) was returned for evaluation.Device history record (dhr) - there is no indication that the production process may have contributed to this complaint.All test results passed procedural specifications.Failure analysis - the perforator unit was inspected using the unaided eye.Anomalies observed were a lightly soiled unit but no other anomalies.Ifu testing procedure was performed and the following was observed, the unit was a frozen inner/outer drill, which was freed by applying pressure, and once freed it performed as intended.Functional testing was performed using the same protocol it underwent at finished goods testing prior to release.The unit was found to perform as intended and fulfilled the acceptance criteria.The complaint could not be verified through failure analysis.The root cause is undetermined and was unable to be confirmed in the complaint evaluation.No further investigation required based on the acceptability of risk and no adverse trends identified.This will be monitored and trended going forward.
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Search Alerts/Recalls
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