CYSTO-URETHRO-FIBERSCOPE

Additional Manufacturer Narrative

DEVICE EVALUATION: THE DEVICE WAS SENT TO THE MANUFACTURER FOR INSPECTION. DURING THE MANUFACTURER'S TECHNICAL INSPECTION, THE ERROR DESCRIPTION "IMAGE QUALITY IS NOT CLEAR" WAS NOT CONFIRMED. A VISUAL AND FUNCTIONAL TEST WAS CARRIED OUT ON THE ENDOSCOPE. HANDGRIP AND HOUSING, ARE IN GOOD CONDITIONS. NO SCRATCHES, NO WEARING MARKS. THE SHAFT IS IN GOOD CONDITION (NO SCRATCHES OR OTHER DAMAGES). THE IMAGE OUTPUT IS SUFFICIENT. THE COMPLAINED FAILURE CANNOT BE CONFIRMED. POSSIBLE CAUSES WHICH CAN LEAD TO THE DESCRIBED ERROR ARE: THE COVER GLASS WAS NOT FREE OF STAINS THAT AFFECT THE IMAGE. ANOTHER DEVICE IN THE IMAGING CHAIN HAD A MALFUNCTION THAT AFFECTED THE IMAGE. THE LIGHT OUTPUT WAS NOT OPTIMALLY ADJUSTED TO THE SURGICAL FIELD, RESULTING IN AN IMAGE THAT WAS NOT OPTIMAL. WHAT ULTIMATELY LED TO THE ERROR DESCRIBED BY THE CUSTOMER CANNOT BE DETERMINED DURING THE INVESTIGATION. THE DEVICE PASSED THE QUALITY CHECK AT THE TIME OF DELIVERY. IN ADDITION, CUSTOMER WILL BE INFORMED AND INSTRUCTED IN THE INSTRUCTION FOR USE IN A SEPARATE COMMUNICATION TO OBSERVE SEVERAL WARNINGS TO AVOID FURTHER MALFUNCTION. THIS EVENT IS FILED UNDER INTERNAL COMPLAINT ID (B)(4).

Description of Event or Problem

IT WAS REPORTED THE IMAGE QUALITY OF THE FLEXIBLE SCOPE IS NOT CLEAR DURING SURGERY. IT IS NOT A BRAND NEW SCOPE AND IMAGE QUALITY IS BAD. DIFFICULTY IN DOING THE CYSTOSCOPY PROCEDURE. PROCEDURE COMPLETED SUCCESSFULLY. SPARE DEVICE WAS USED TO COMPLETE PROCEDURE. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

Additional Manufacturer Narrative

THE DEVICE IN QUESTION WAS RETURNED TO 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).