Description of Event or Problem · 1
DURING RETROGRADE PYELOGRAM-TIP BROKE OFF BRAASCH BULB TIP URETERAL CATHETER. SURGEON WAS ABLE TO RETRIEVE TIP WITH BIOSPY FORCEPS. SURGEON PROCEEDED WITH SURGICAL PROCEDURE-TRANSURETHRAL RESECTION OF BLADDER TUMOR. PT HAD POST-OP BLEEDING WITH UNEXPECTED TRANSFER TO ICU-RECEIVED A TOTAL OF 5 UNITS OF PRBCS. UNABLE TO DETERMINE WITH CERTAINTY, PERCENTAGE OF RESPONSIBILITY TO BE ASSIGNED TO LOSS OF URETERAL CATHETER TIP. PT WAS DISCHARGED ALIVE FOR 10 DAY HOSP STAY. SIX DAYS IN ICU.DEVICE 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.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT. METHOD OF EVALUATION: NO DATA. RESULTS OF EVALUATION: NO DATA. CONCLUSION: INVALID DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: DEVICE RECALLED BY MANUFACTURER/DISTRIBUTOR, USE OF ALL SIMILAR DEVICES STOPPED TEMPORARILY, NONE OR UNKNOWN. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.