The device was returned to the manufacturing location for further investigation.The complaint was able to be confirmed through main frequency hi-pot test 4243 vrms for 30 seconds.The device failed the test and arced through the pencil handle.The root cause according to the supplier was an issue with the parameters of the ultrasonic welding machine not being adequate and caused a failure of the test.A corrective action is being taken by the supplier to review the current utrasonic welding parameters and validation and making the updates necessary.The next three months of inspection records will be collected after the corrective actions are completed.The complaint rate is low with the only additional complaint being from the same customer.Based on the investigation, this can be seen as the final report.If additional information is obtained that alleges any additional patient involvement or need for additional corrective actions, a follow up report will be submitted.
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