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 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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This is 4 of 4 reports linked to mfg report numbers: 3014334038-2022-00092, 3014334038-2022-00093, and 3014334038-2022-00094.A facility reported a disposable perforator (id 261221) did not stop when it went through the bone and injured the dura.The event did not led to surgical delay.
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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.No anomalies were observed since the returned unit was a new sample, representative of the perforator used in surgery.Ifu testing procedure was performed with no observed anomalies.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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Manufacturer Narrative
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Root cause analysis - potential root cause includes user misuse.
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Event Description
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N/a.
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Search Alerts/Recalls
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