Description of Event or Problem · 1
THE OLYMPUS UPPER ENDOSCOPY SCOPE (GIF 100) WAS BEING USED FOR AN EGD WITH PEG PLACEMENT. THE MD EXPERIENCED DIFFICULTY WITH THE SCOPE AND ON FURTHER INVESTIGATION FOUND THE TIP OF THE CLEANING BRUSH. THIS BRUSH HAD BEEN UTILIZED IN A PRIOR PROCEDURE AND THE TIP L;ODGED IN THE SCOPE. NO HOSPITAL PERSONNEL HAVE KNOWLEDGE OF THE TIP BEING OFF DURING CLEANING AND ALL BRUSHES WERE IN GOOD SHAPE THE DAY PRIOR UNTIL 1530. THE BRUSH WAS ACTUALLY DISLODGED INTO PATIENT BUT WAS RETRIEVED. INSERVICING HAS ALREADY OCCURRED. THE POLICY/PROCEDURE MANUAL WILL BE CHANGEDDEVICE NOT LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: FAIR 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: END OF LIFE - PREMATURE, TELEMETRY FAILURE, RELATED TO ANOTHER DRUG/DEVICE, OTHER. CONCLUSION: DEVICE FAILURE DIRECTLY CAUSED EVENT, DEVICE FAILURE DIRECTLY CONTRIBUTED TO EVENT, USER ERROR CONTRIBUTED TO EVENT. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: DEVICE DISCARDED, USER EDUCATION PROVIDED, OTHER. THE DEVICE WAS DESTROYED/DISPOSED OF.