Description of Event or Problem · 1
AN EMG WAS BEING PERFORMED ON THE PATIENT, SPECIFICALLY THE GLUTEUS MEDIUS MUSCLE, WHEN THE NEEDLE PROBLE SNAPPED OFF AT THE BASE OF THE HUB. THE NEEDLE WAS BEING MOVED THROUGH DIFFERENT MOTOR UNITS WHEN THE NEEDLE SEPARATED FROM THE HUB. THE NEEDLE WAS NOT ACCESS IBLE TO SURFACE REMOVAL, SO THE PATIENT WAS TAKEN TO THE OPERATING ROOM WHERE THE NEEDLE WAS REMOVED UNDER GENERAL ANESTHESIA.DEVICE NOT LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: SATISFACTORY 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. NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, VISUAL EXAMINATION. RESULTS OF EVALUATION: NONE OR UNKNOWN. CONCLUSION: DEVICE FAILURE DIRECTLY CONTRIBUTED TO EVENT. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: DEVICE DISCARDED, USER EDUCATION PROVIDED, INSERVICED BY OTHER FACILITY STAFF. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.