Though medical/surgical intervention was required to preclude a serious injury in this event, there have been previously reported events involving a similar device that resulted in the need for medical/surgical intervention to preclude permanent damage to a body structure or permanent impairment of a body function.Therefore, this event meets the criteria for reportability per 21 cfr part 803.Initial observations supported the reported complaint.Production & quality testing of the handpiece was not performed as the device came in missing a cartridge.Multiple dimensions on the head and cap were checked by production personnel.Dentsply is unable to determine how the cap might have come unscrewed as all handpieces are 100% performance tested prior to shipping.
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