INNER SHEATH FOR 27050 SC

Additional Manufacturer Narrative

BELATED EVALUATION AND REPORTING OF THIS COMPLAINT WAS DONE DURING RETROSPECTIVE REVIEW AS PART OF CAPA 20-0052 CORRECTIVE ACTION 6. UPON EVALUATION THE SHEATH WAS FOUND TO BE BROKEN OFF FROM THE CONNECTOR. THE SHEATH IS SHOWING SEVERAL DENTS AND DEFORMATIONS, WHICH SUSPECT IMPACTS ON/WITH HARD OBJECTS. FURTHERMORE, THE SURFACE SHOWS GRINDING MARKS. THE SURFACE AROUND THE BREAKAGE SHOWS ADHESIVE RESIDUES. THE CONNECTOR SHOWS SEVERAL USAGE MARKS AND DENTS, WHICH SUSPECTS MECHANICAL DAMAGE. THE CERAMIC TIP ALSO SHOWS USAGE MARKS AND DISCOLORATIONS. THE DAMAGES PRESENT SUSPECT THE DEVICE WAS IN USE FOR SEVERAL YEARS. THE DEVICE WAS MANUFACTURED 15TH NOV. 2013. THE ROOT CAUSE MOST LIKELY IS MECHANICAL OVERLOAD WHICH LEAD TO THE BREAKAGE OF THE SHEATH. NO INDICATIONS FOR A MATERIAL OR MANUFACTURING RELATED ISSUE COULD BE FOUND DURING INVESTIGATION. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID (B)(4).

Description of Event or Problem

IT WAS REPORTED THAT DURING A PORSTATIC ENUCLEATION SURGICAL PROCEDURE WITH A HOLMIUM LASER, THE ROTATING INTERNAL SHEATH OF THE LASER RESECTOR WAS BROKEN, RESULTING IN MINIMAL BLADDER OPERATION. AN ELECTRO COAGULATION OF THIS BLADDER PERFORATION WAS PERFORMED. THE PATIENT IS DOING WELL. NO FURTHER INFORMATION AVAILABLE.