QUATERA 700

Additional Manufacturer Narrative

H6: TYPE OF INVESTIGATION - ADDED 10, TESTING OF ACTUAL/SUSPECTED DEVICE; INVESTIGATION FINDINGS - CHANGED FROM 3233 (RESULTS PENDING COMPLETION OF INVESTIGATION) TO 4248 (USAGE PROBLEM IDENTIFIED); INVESTIGATION CONCLUSIONS - CHANGED FROM 11 (CONCLUSION NOT YET AVAILABLE) TO 19 (CAUSE TRACED TO USER) CUSTOMER RECEIVED 2 NEW HANDPIECES AND NO FURTHER ISSUES WERE REPORTED. SYSTEM WORKS WITHOUT ISSUES WITH THE NEW HANDPIECES. THE INVESTIGATION CARRIED OUT BY MANUFACTURER SHOWS THE ISSUE OCCURRED DUE TO A USER ERROR. THE HANDPIECES USED BY THE CUSTOMER ARE OVER THE LIFETIME AND HAS BROKEN CABLE PROBABLY CAUSED BY TOO TIGHT A ROLL/LAP OR BY PULLING THE CABLE. THE AFFECTED HANDPIECES ARE OVER THE LIFETIME (9 YEARS & 11 YEARS OF USE) AND WORN-OUT THROUGHOUT APPROXIMATELY 300 REPROCESSING CYCLES/YEAR. THE ULITE HP IFU CLEARLY DESCRIBES THAT THE HANDPIECES ARE SPECIFIED FOR 600 REPROCESSING CYCLES AND ANY USE BEYOND THE GIVEN REPROCESSING CYCLES, OR THE USE OF DAMAGED AND / OR CONTAMINATED COMPONENTS IS THE SOLE RESPONSIBILITY OF THE USER. CUSTOMER HAS BEEN RETRAINED ON THE MAXIMUM STERILIZATION CYCLES AND THAT IS NOT POSSIBLE THE REUTILIZATION OF THE CASSETTES. THIS INCIDENT WAS CAUSED BY A USER ERROR, WHICH WAS NOT DUE TO ERGONOMIC FEATURES, AS WELL AS ANY INADEQUACY IN THE INFORMATION SUPPLIED BY THE MANUFACTURER. THERE IS NO SIGN FOR A SYSTEMATIC FAILURE. BASED ON THE INFORMATION REVIEWED, THERE IS NO EVIDENCE TO INDICATE THE PRESENCE OF A POTENTIAL QUALITY ISSUE WITH RESPECT TO MANUFACTURING, DESIGN OR LABELING. FOLLOWING THE RISK-BASED APPROACH, NO FURTHER ACTIONS ARE REQUIRED.

Additional Manufacturer Narrative

THE EXACT ROOT CAUSE HAS NOT BEEN DETERMINED YET. A MALFUNCTION OF A COMPONENT OR WORN OUT HANDPIECE IS POSSIBLE. THE ROOT CAUSE INVESTIGATION IS STILL IN PROGRESS. IN THE IFU IT IS CLEARLY NOTED TO TAKE ADEQUATE PRECAUTIONS SO THAT THE SURGERY CAN BE COMPLETED IN CASE A MALFUNCTION OCCURS.

Description of Event or Problem

CUSTOMER IN SPAIN REPORTED THAT PHACOEMULSIFIER CALIBRATION PROCESS STOPPED AT 20% DURING A CATARACT SURGERY. THIS HAPPENED AT THE BEGINNING OF THE 3RD SURGERY OF THE DAY. THE CATARACT SURGERY COULD NOT BE COMPLETED WITH THE SAME DEVICE. THE PATIENT WAS TRANSFERRED TO ANOTHER HOSPITAL WHERE THE SURGERY WAS COMPLETED WITH A DELAY OF 5 HOURS.