Device used for treatment, not diagnosis.Additional narrative: patient information not available for reporting.Device is an instrument and is not implanted/explanted.(b)(6).Subject device has been received and is currently in the evaluation process.Investigation is ongoing; no conclusion could be drawn as product is entering the complaint system.Device history records review was conducted.Dhr review for 03.111.005 / 7598175; manufacturing location: (b)(4); manufacturing date: 24.Nov.2011.No ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
|
Product development investigation was completed.The returned depth gauge was tested and the complaint condition could be confirmed, as it was rough running as reported.Investigation of documentation for production and material gives evidence that the instrument was produced under specifications in nov, 2011.Failure in material or production could not be detected.The instrument was lubricated with synthes special oil during the investigation and was then freely movable as required.The problem as per complaint description could not be duplicated anymore.Therefore we assume that the instrument was not lubricated as per the instructions provided by the manufacturer.As per the leaflet ¿important information¿ moving instrument parts, e.G.Joints, sliding parts, dismountable threaded connections etc.Must be regularly lubricated.Based on these findings we conclude that the cause of failure is not due to any manufacturing non-conformances.No indication for product related issue was found.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
|