Catalog Number 261221 |
Device Problems
Break (1069); Activation, Positioning or Separation Problem (2906)
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Patient Problem
Brain Injury (2219)
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Event Date 10/06/2020 |
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 nurse reported the perforator perforated the dura and broke into pieces after extraction.All the broken parts were recovered.
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Event Description
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N/a.
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Manufacturer Narrative
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The codman disposable perforator 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: a disassembled perforator with worn eto label and heavy organic matter were observed.The "ifu" testing procedure was performed with no observed anomalies.The 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.Product was received for analysis and the investigation could not confirm the complaint.
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Search Alerts/Recalls
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