Catalog Number 261221 |
Device Problem
Activation, Positioning or Separation Problem (2906)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/30/2021 |
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 perforator during an acute subdural hematoma procedure.Surgical time was extended less than 30 minutes and the procedure was completed with another product available.The patient postoperative progress was good.It is unknown the drill manufacturer, 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.No further information was provided by hospital.
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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.Unit was soiled with organic material but presented no other anomalies.The "ifu" testing procedure was performed with no observed anomalies.The inner and outer drill were freed with light pressure, and functioned as intended.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.
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Search Alerts/Recalls
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