CYSTO-URETHRO-FIBERSCOPE

Description of Event or Problem

IT WAS REPORTED THAT THE DEVICE SHOWS A BROKEN SHEATH. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

Additional Manufacturer Narrative

THE DEVICE IN QUESTION WAS RETURNED MANUFACTURER. THIS INFORMATION IS REFLECTED IN SECTION D9. THE EVALUATION IS ANTICIPATED, BUT NOT YET BEGUN. THE INVESTIGATION WILL BE PERFORMED BY A DESIGNATED KARL STORZ EMPLOYEE. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: (B)(4).

Additional Manufacturer Narrative

DEVICE EVALUATION: THE DEVICE WAS SENT TO THE MANUFACTURER FOR INSPECTION. DURING THE MANUFACTURER'S TECHNICAL INSPECTION, THE ERROR DESCRIPTION BROKEN SHEATH WAS NOT CONFIRMED. THE FOLLOWING DAMAGES WERE FOUND DURING VISUAL AND FUNCTIONAL INVESTIGATION: ---THE SHAFTS MARKING RINGS ARE BROWNISH DISCOLORED. ---THE SHEATHING OF THE SHAFT IS BRITTLE AND TORN IN SEVERAL PLACES. ---THE HOUSING AND THE HANDLE SHOW SLIGHT SIGNS OF WEAR. THE CHECKLIST PROVIDED BY CUSTOMER WAS DOUBLE CHECKED AND EVALUATED. DUE TO THE DAMAGES FOUND AND THE EVALUATION OF THE CHECKLIST IT CAN BE DETERMINED THAT THE REASON FOR THE BURST SHAFT IS DUE TO NON-COMPLIANT REPROCESSING. THE FAILURE CAN BE TRACED BACK TO A USER/REPROCESSING ERROR. THE DEVICE PASSED THE QUALITY CHECK AT THE TIME OF DELIVERY. THIS EVENT IS FILED UNDER INTERNAL COMPLAINT ID (B)(4).

Additional Manufacturer Narrative

ADDITIONAL INFORMATION IS PROVIDED IN SECTION B5. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: (B)(4).

Description of Event or Problem

ADDITIONAL INFORMATION WAS PROVIDED THAT THERE WAS THE ISSUE WAS IDENTIFIED FOLLOWING STERILIZATION PROCEDURE AND NOT DURING THE PROCEDURE. THE BROKEN PART DOES NOT EXIST AS THE SHEATH WAS CORRODED AND TORN. THERE WAS NO PATIENT INVOLVMENT IN THIS EVENT.