INNER SHEATH FOR 27050 SC

Additional Manufacturer Narrative

CORRECTION IS PROVIDED IN SECTIONS B1, B2, AND H1. 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

CORRECTION: THE LAST SUPPLEMENTAL REPORT WAS TO CORRECT THE SEVERITY OF THE EVENT FROM MALFUNCTION TO ADVERSE EVENT. THE EVALUATION WAS COMPLETED AND REFLECTED IN THE INITIAL REPORT. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: (B)(4).

Additional Manufacturer Narrative

RESULT OF INVESTIGATION COMPLETED ON OCTOBER 29, 2024: ACCORDING TO THE CUSTOMER, THE CERAMIC BEAK BROKE DURING THE PROCEDURE. THE ARTICLE SHOWS DAMAGE TO THE SHAFT DUE TO USE SIGNS. THE DAMAGE MAY HAVE BEEN CAUSED BY EXCESSIVE FORCE DURING USE OR SIGNS OF WEAR AND TEAR. IN THIS CONTEXT, THE IFU POINTS OUT THAT DAMAGE TO THE SHAFT MAY HAVE A NEGATIVE EFFECT ON THE CERAMIC BEAK. THEREFORE, IT IS POINTED OUT IN THE INSTRUCTIONS FOR USE THAT CERAMIC COMPONENTS SHOULD BE CHECKED FOR DAMAGES SUCH AS CRACKS, CHIPPING, ETC. BEFORE EACH USE. THE DEVICE HISTORY RECORDS HAVE BEEN CHECKED AND FOUND TO BE ACCORDING TO THE SPECIFICATION, VALID AT THE TIME OF PRODUCTION. THERE IS NO INDICATION FOR A MATERIAL OR MANUFACTURING FAILURE. THE FAILURE IS MOST PROBABLY USAGE RELATED. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: (B)(4).

Description of Event or Problem

IT WAS REPORTED THAT AFTER A CASE OF HOLMIUM LASER ENUCLEATION OF PROSTATE AND CYSTOLITHOTRIPSY, A CERAMIC TIP 0.9MM (L) AND 0.8MM (D) OF THE RESECTOSCOPE INNER SHEATH WAS FOUND BROKEN WITH MISSING PIECES DURING AN INSTRUMENT CHECK BEFORE BEING TRANSFERRED TO THE TSSU. A SEARCH OF THE ENVIRONMENT WAS CONDUCTED BUT IN VAIN. THE SURGEON WAS INFORMED AFTERWARD, A PELVIC X-RAY WAS PERFORMED AND NO OBVIOUS FOREIGN BODY FOUND. THE PATIENT WAS INFORMED BY THE SURGEON IN WARD.