Reference code gb740r, device name hi-line xs craniotome handpiece, serial number (b)(6), batch number 4504734138, udi device identifier (b)(4), udi production identifier (b)(4), basic udi-di n/a, unit of use udi-di (b)(4), manufacturing date 18.01.2013.Investigation results: to date there is no device available for investigation.Therefore, no investigation possible.Batch history review: the device quality and manufacturing history records (dhr) have been checked for all available lot numbers and the products found to be according to our specification valid at the time of production.There are no similar complaints against the same lot number(s) with this error pattern.The current failure rate is within the risk analysis and therefore acceptable.Conclusion and measures / preventive measures: based on the provided information and without a product, a definitive root cause can not be determined.According to our database, the product was delivered in april 2013.A maintenance and/or a repair was not registered since that date.Furthermore, it was reported that the device was repaired/maintained by a third party.According to the corresponding ifu, a maintenance should take place on regular basis by the manufacturer and as indicated on the laser engraving on the product.On the basis of the current information and without the product for investigation, a clear conclusion cannot be drawn.There is no indication for a material defect, manufacturing failure or design error on the basis of the device history record.For further investigations we need the product for examination.Based on the investigations and results of the 8d report a capa is not necessary.Se.
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