INNER SHEATH FOR 27050 SC

Additional Manufacturer Narrative

EVALUATION FINDINGS: ACCORDING TO THE CUSTOMER, THE CERAMIC BEAK WAS BROKEN DURING THE PROCEDURE. IT IS VERY LIKELY THAT THE ARTICLE SHOWS DAMAGE TO THE SHAFT DUE TO USE SIGNS. IN ADDITION, 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 YOU SHOULD CHECK THE CERAMIC COMPONENTS FOR DAMAGE SUCH AS CRACKS, CHIPPING, ETC. BEFORE EACH USE. INTERNAL KARL STORZ REFERENCE NUMBER: (B)(4).

Additional Manufacturer Narrative

THIS MDR IS TO CORRECT THE PREVIOUS SUPPLEMENTAL REPORT IN SECTION G3. INTERNAL KARL STORZ REFERENCE NUMBER: (B)(4).

Description of Event or Problem

IT WAS REPORTED THAT DURING A TRANSUETHRAL RESECTION OF THE BLADDER, AFTER EMPTYING THE BLADDER, THE RESECTOSCOPE WAS INSERTED CORRECTLY AND IT WAS FOUND THAT THE CERAMIC TIP HAD BROKEN OFF AND WAS FLOATING IN THE BLADDER. FORTUNATELY, THE BROKEN CERAMIC PARTICLE COULD BE REMOVED FROM THE BLADDER TRANSURETHRALLY BUT THE ANESTHESIA TIME WAS EXTENDED AS A RESULT.

Additional Manufacturer Narrative

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