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 TIP IS BROKEN IN ITSELF. HOWEVER, SLIGHT DISCOLORATION DUE TO FIRE DAMAGE IS VISIBLE AT THE DISTAL END. THE CERAMIC TIP HAS BEEN MACHANICALLY OVERLOADED - DAMAGES LIKE THIS HAPPEN IF THE CERAMIC INSERT IS HIT AGAINST HARD OBJECTS ORD EDGES. DURING INTENDED USE, THERE IS NO POSSIBILITY TO APPLY FORCES TO ACHIEV THE DEFECTS. THE WARNING NOTICES WITH THE CORRESPONDINGIFU INDICATE THIS. THE BURN MARKS INDICATE TOO HIGH/ TOO LONG EXPOSURE TO HEAT. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID (B)(6).

Description of Event or Problem

IT WAS REPORTED THAT DURING THE BIPOLAR RESECTION, THE BREAKAGE OF THE TERMINAL GRAY PLASTIC COMPONENT OF THE ROTARY SHEAT OCCURED WHICH REQUIRED AN ENDOSCOPIC EVACUATION OF ALL THE PLASTIC PIECES OF THE SHEAT FROM THE BLADDER OF THE PATIENT.