During investigation of mfr no.9612186-2017-00008 ((b)(4)), additional information of frame slippage incidents were received from the customer.The customer has reported that after the first of five treatment shots/positions, the frame came loose during manual shot position adjustment.A second frame fixation was then used to complete the treatment.
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The investigation has been performed based upon the information given by the hospital.As the incidents occurred between 8 to 14 years ago, the information from the events are limited.There is no information on what products were used at the time of the incidents (e.G.Frame, posts or fixation screws), but according to the neurosurgeon there was no evidence that equipment failure was involved in the events.The equipment is therefore excluded to the cause of the incidents.Due to the time span of the occurrence of the events, it has not been possible to identify the root cause of the incident.A probable root cause may be that the frame was not firmly attached to the patient skull prior to treatment, and/or patient movement during gamma knife treatment.No field safety corrective action would be initiated.
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