Description of Event or Problem · 1
PATIENT WAS IN OR FOR TURP PROCEDURE. CONTINUOUS FLOW AS BEING UTILIZED FOR THE PROCEDURE. WHEN THE PUMP WAS TURNED ON IT WAS NOTICED THAT THE FLUID WAS GOING BACK INTO THE IRRIGATION BAG. THE PHYSICIAN WAS ADVISED AND STOPPED. TUBING WAS REPOSITIONED AND PROCEDURE RESUMED. UPON EXAM SURGEON NOTED THAT THE BLADDER LOOKED ODD. X-RAYS WERE TAKEN AND VERIFIED THAT THE BLADDER WAS PERFORATED ON THE RIGHT SIDE. TURP WAS CANCELLED, FOLEY CATH PLACED TO ALLOW BLADDED TO HEAL.DEVICE NOT LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: SATISFACTORY CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.DEVICE SERVICED IN ACCORDANCE WITH SERVICE SCHEDULE. DATE LAST SERVICED: . SERVICE PROVIDED BY: USER FACILITY BIOMEDICAL/BIOENGINEERING DEPARTMENT. SERVICE RECORDS AVAILABLE.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, MECHANICAL TESTS PERFORMED, VISUAL EXAMINATION. RESULTS OF EVALUATION: LABELING - INADEQUATE INSTRUCTIONS FOR USE, INCORRECT TECHNIQUE/PROCEDURE, UNANTICIPATED ADVERSE REACTION - SHORT TERM, OTHER. CONCLUSION: INVALID DATA, DEVICE WAS OUT OF SPEC IN A MANNER THAT RELATES TO EVENT. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: DEVICE TEMPORARILY REMOVED FROM SERVICE, INSERVICED BY MANUFACTURER/DISTRIBUTOR REPRESENTATIVE. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.