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Patient 1
A DISPOSABLE CRAINAL PERFORATOR WAS USED TO MAKE A BURR HOLE FOR CRANIOTOMY. THE PERFORATOR WAS SUPPOSED TO GO FORWARD 3MM INTO SKULL BUT, ACCORDING TO THE SURGEON, WENT FURTHER, PIERCING THE DURA AND STOPING AT THE FRONTAL LOBE. BRAIN SWELLING WAS NOTICED, FLAP OPPENED AND EDEMA REDUCED BY MEDICATION. FLAP COLOSED AND PATIENT MONITORED IN SICU. ORIGINALLY SCHEDULED SURGERY FOR ANEURYSM TO BE SCHEDULED T LATER DATE WHEN PATIENT IS DEEMED STABLE. AT PRESENT, PATIENT HAS RETURNED TO PRE-OP STATUS. OUTSIDE LAB INVESTIGATING THE PERFORATOR WHICH IS IN PROGRESSDEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: CRITICAL CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY. INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD. DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, OTHER, OTHER, INVALID DATA. RESULTS OF EVALUATION: NONE OR UNKNOWN, NONE OR UNKNOWN, NONE OR UNKNOWN. CONCLUSION: NO DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: DEVICE TEMPORARILY REMOVED FROM SERVICE. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.