CALCULASE III FIBER 600 ¿M REUSABLE

Additional Manufacturer Narrative

THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: (B)(4). THE DEVICE IN QUESTION WAS RETURNED TO THE 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.

Additional Manufacturer Narrative

RESULT OF INVESTIGATION: THE PART OF THE CUSTOMER'S COMPLAINT THAT THE FIBER IS DAMAGED CAN BE CONFIRMED AFTER AN INVESTIGATION. HOWEVER, SUCH DAMAGE CANNOT OCCUR AFTER A PROGRAM CHANGE. A PRODUCTION DEFECT CAN BE RULED OUT BECAUSE, ACCORDING TO THE "FREQUENCY OF USE" LABEL, THE FIBER HAS ALREADY BEEN REPROCESSED FIVE TIMES AND CAN THEREFORE BE ASSUMED TO HAVE BEEN USED FIVE TIMES. IF THE FIBER HAD BEEN DAMAGED FROM THE START, IT WOULD HAVE BEEN DAMAGED BY THE LASER ENERGY DURING THE FIRST APPLICATION. THE MOST PROBABLE ROOT CAUSE IS THEREFORE THAT THE FIBER BROKE DURING REPROCESSING OR APPLICATION. WHEN A FIBER BREAKS, THE LASER ENERGY OCCURS AT THE POINT OF BREAKAGE AND CAN CAUSE DAMAGE. THIS WOULD ALSO CAUSE THE POWDER MARKS THAT CAN BE SEEN INSIDE. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: (B)(4).

Description of Event or Problem

IT WAS REPORTED THAT WHEN CHANGING THE PROGRAM OF THE FIBER LASER 600 MODE VAPORIZATION, A BREAKAGE OF THE LASER FIBER WAS CAUSED. WHEN THE SURGEON USED THE LASER AGAIN, SPARKS AND EXPLOSION AT THE LEVEL OF THE RED TIP - LASER FIBER TORN OFF. THIS RESULTED IN DISCONTINUATION OF THE PROCEDURE AND CHANGE OF THE EQUIPMENT.

Additional Manufacturer Narrative

THE AFFECTED DEVICE HAS BEEN REQUESTED FOR INVESTIGATION BY THE MANUFACTURER. THE DEVICE WAS NOT YET RETURNED FOR INVESTIGATION. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: (B)(4).