INNER SHEATH FOR 27050 SL

Additional Manufacturer Narrative

BELATED EVALUATION AND REPORTING OF THIS COMPLAINT WAS DONE DURING RETROSPECTIVE REVIEW AS PART OF CAPA 22-0074 CORRECTIVE ACTION 12. THE CERAMIC BEAK SHOWS A SECTION BROKEN OFF. THE BROKEN SURFACE IS PARTIAL DISCOLOURED, WHICH INDICATES A PRE-DAMAGE. A CORRESPONDING SECTION FOR INSPECTION OF THE CERAMIC BEAK IS ALREADY INCLUDED IN THE IFU. THIS DAMAGE SHOULD HAVE BEEN DETECTED RIGHT AFTER USE, AS AN INSPECTION OF THE USED DEVICES IN MANDATORY POST PROCEDURE. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID ((B)(4)).

Description of Event or Problem

IT WAS REPORTED THAT THE PATIENT RETURNED TO HOSPITAL AFTER A SURGERY ON SUNDAY (B)(6)2018, DUE TO BLEEDING. UPON A CYSTOSCOPY A SIGNIFICANT AMOUNT OF BLADDER STONES WERE FOUND IN THE BLADDER. THE BLADDER STONES WERE CRUSHED AND EXTRACTED FROM PATIENT. UPON EXTRACTION A PIECE OF PLASTIC WAS FOUND AND IT WAS NOT FROM SET IN USE. THE SET WHICH WAS USED IN THE ORIGINAL SURGERY DATED (B)(6) 2018 WAS CHECKED AND AT THE INNER SHEATH, A MISSING PIECE WAS FOUND WHICH FITED TO THE PIECE OF PLASTIC FOUND IN THE BLADDER.