Description of Event or Problem · 1
POSITIVE SPORE FROM GAS LOAD NUMBER ONE ON 1/3/95. SIX ITEMS WERE IN THE LOAD AS FOLLOWS: 1 WHITE BASIN; 1 BIPOLAR CORD; 1 CYSTO CORD; 1 MIRROR #1; 1 BIPOLAR FORCEP; 1 GREY CORD SOLO. UPON NOTIFICATION OF POSITIVE SPORE ON 1/5/95, AND POSSIBLE CONTAMINATION TO LOAD, ITEMS WERE RECALLED. THREE ITEMS WERE RETURNED UNUSED; OTHER POSSIBLY CONTAMINATED ITEMS MAY HAVE BEEN USED ON ANY OF FOUR SURGICAL PTS. PHYSICIANS WERE NOTIFIED OF POSSIBLE CONTAMINATION. ALL PARAMETERS OF STERILIZATION, WITH THE EXCEPTION OF THE POSITIVE SPORE, WERE OKAY. SPORE IS RUN WITH EVERY LOAD-LOAD PRIOR AND POST TO THE POSITIVE SPORE WERE NEGATIVE. SERVICE COMPANY CONTACTED AND ADJUSTMENTS TO THE HUMIDITY WERE MADE. POSSIBILITY OF INCORRECT READING ON THE SPORE THAT WAS POSITIVE. ONE OF THE FOUR PTS HAVING A VAGINAL HYSTERECTOMY WAS READMITTED TO FACILITY ON 1/13/95 WITH POST-OP ILLNESS. CULTURES RAN TO DETERMINE INFECTION WERE NEGATIVE. NO REPORTED PROBLEMS WITH THREE REMAINING PTS.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE. PATIENT MEDICAL STATUS PRIOR TO EVENT: SATISFACTORY CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.DEVICE SERVICED IN ACCORDANCE WITH SERVICE SCHEDULE. DATE LAST SERVICED: 01-NOV-94. SERVICE PROVIDED BY: INDEPENDENT SERVICE ORGANIZATION. 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, INVALID DATA. RESULTS OF EVALUATION: STERILIZATION. CONCLUSION: NONE OR UNKNOWN. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: INSERVICED BY MANUFACTURER/DISTRIBUTOR REPRESENTATIVE. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.