Model Number 261221 |
Device Problem
Fail-Safe Did Not Operate (4046)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/24/2023 |
Event Type
malfunction
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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 disposable perforator (id (b)(6)) during surgery.It occurred at making the first burr hole at the tent.Since it was used without pressing, it was said that it did not lead to damage to the dura mater.The procedure was completed with a replacement product available.Surgical time was extended less than 30 minutes.The patient recovered.The manufacturer of the drill used with the perforator was bien air/yufu.According to information provided, it is unknown if the drill was electric or pneumatic, and it is unknown if the perforator clicked in place on the drill.It is also unknown if the recommended spring tests were performed between each burr hole.In addition, it is unknown if the perpendicular approach maintained through the drilling process or if there was any rocking motion included, and also unknown if there was constant downward pressure.
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Manufacturer Narrative
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The codman 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 - a visual inspection was performed utilizing the unaided eye, unit was lightly soiled and had a partially worn eo label.A spring test was performed, unit passed the spring test and functioned as designed.Functional test performed, unit successfully drilled 5 holes with no issues.Therefore, the complaint condition could not be confirmed.The root cause is undetermined and was unable to be confirmed in the complaint evaluation.However, the possible root cause is: ''user misuse¿ or drill allows to be set incorrectly¿.
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Event Description
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N/a.
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Search Alerts/Recalls
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