General information: we received a complaint about a gd805r - hi-line craniotome cutter ii regarding an intraoperative issue.We did not receive the complained product for investigation.Consequences for the patient: according to the provided information, there were no negative consequences for the patient.Investigation: due to a lack of components, a failure description is not possible.Batch history review: the device history records have been checked for the available lot number and found to be according to the specification, valid at the time of production.There are no further complaints registered against the same lot number (52459504).Conclusion and root cause: the failure is most probably usage related.Rationale: on the basis of the current information and without the product, a clear conclusion can not be drawn.After a dhr, a manufacturing related error can be excluded.Furthermore there is no indication for a material failure.It is possible that an overload situation in combination with wear an tear led to the breakage of the cutter.According to the ifu, the product has to be checked before each usage.Blunt tools shouldn't be used.Furthermore, based on the statistical analysis, there is no indication for a systematic failure.Corrective action: a capa is not necessary according to sop sa-de13-m-4-2-04-000-0 (corrective action and preventive action).
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