CALCULASE III FIBER 230 ¿M REUSABLE

Additional Manufacturer Narrative

AN INCORRECT ADDRESS WAS PROVIDED IN SECTION G1 IN THE INITIAL REPORT. THIS SUPPLEMENTAL REPORT IS TO PROVIDE THE CORRECT CONTACT INFORMATION FOR THIS SECTION. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID (B)(4).

Additional Manufacturer Narrative

WHEN TESTING THE OPTICAL FIBER, THE TOTAL LENGTH OF THE FIBER INCLUDING THE HANDLE WAS MEASURED AT 1600MM. ACCORDING TO THE DRAWING, THE TOTAL LENGTH OF THE FIBER SHOULD BE 3000MM +/-200MM. ACCORDING TO THE CUSTOMER, THE FIBER BROKE DURING USE. ACCORDING TO THE CUSTOMER, THE BROKEN PIECE COULD BE RECOVERED. THE BROKEN END HAS A SMOOTH AND SUBER STRUCTURE. IN COMPARISON TO THE RESULT OF THE INTERNAL BREAKAGE TEST, NO COMPLETE BREAKAGE / SEPARATION COULD BE RECREATED HERE. THE FIBER WAS CLAMPED AND ANGLED AT 90° FOR THIS PURPOSE. THE FRACTURE SHOWS NO SEPARATION OF THE GLASS FIBER AND THE CLADDING. WE THEREFORE ASSUME THAT THIS IS NOT A PRODUCTION DEFECT. RATHER, WE ASSUME THAT THE BREAK WAS CAUSED BY A SHEARING/CUT BY THE USER DURING USE OF THE FIBER. NO FURTHER MEASURES WILL BE INITIATED. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: (B)(4).

Additional Manufacturer Narrative

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

Description of Event or Problem

IT WAS REPORTED THAT A FRAGMENT OF FIBER BROKE OFF IN PATIENT DURING PROCEDURE AFTER SECOND USE OF FIBER.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION IS PROVIDED IN SECTION D9 TO REFLECT THAT THE PRODUCT WAS RETURNED FOR EVALUATION. THE ITEM IN QUESTION WAS RETURNED TO THE MANUFACTURER. THE INVESTIGATION IS NOT COMPLETED YET. THE INVESTIGATION RESULTS ARE PENDING. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID:(B)(4).