This complaint investigation was closed based on the device not received, therefore the reported failure mode was not confirmed.In the event that the device is received, the complaint will be reopened and the investigation will be updated with new results.Alleged failure: could not be turned off.Probable root cause: probe short, button stuck on firing position, fluid ingress, suction tube cut, button inadvertently pressed, damaged insulation, probe bender used to bend nonbendable probe, user accidentally submerges device, inadequate gluing operations (tip and core/lumen) or inadequate gluing/welding of core to handle console error: refer to (b)(4) for risk outputs associated with rf energy to probe for the serfas energy console.Refer to (b)(4) for risk outputs associated with rf signal to handpiece for crossfire and crossfire ii consoles use error the reported failure mode will be monitored for future reoccurrence.
|