FIBERSCOPE, INTUBATION, FLEX, 0º,

Additional Manufacturer Narrative

RESULT OF INVESTIGATION: THE ERROR DESCRIBED BY THE CUSTOMER "THE SUCTION CONNECTOR HAS BEEN BROKEN DURING BRONCHOSCOPY (BROKEN AT THE BASE WHERE IT ATTACHES TO THE BRONCHOSCOPE), CAUSING COMPLETELY THE SPRING INSIDE TO DETACH" COULD NOT BE CONFIRMED AS THE ENDOSCOPE WAS NOT RETURNED. THE CONDUCTED INVESTIGATIONS DID NOT REVEAL A ROOT CAUSE RELATED TO THE LABELLING, THE DEVICE OR ITS HISTORY. ALL PRODUCTION RELATED QUALITY CHECKS WERE PASSED, AND NO NON-CONFORMITIES WERE IDENTIFIED IN THE DEVICES MANUFACTURING RECORDS. THE LABELLING WAS FOUND TO CONTAIN ADEQUATE INSTRUCTIONS AND WARNINGS. THE COMPLAINT HISTORY REVIEW DID NOT REVEALED ANY SIMILAR COMPLAINTS WITH BREAKAGE OF THE SUCTION NOZZLE ON THE ENDOSCOPE. THE MOST LIKELY CAUSE ACCORDING TO THE CUSTOMER'S DESCRIPTION IS THAT THE SUCTION VALVE (11301CB) WAS NOT PROPERLY INSTALLED AFTER REPROCESSING AND OPENED SO THAT THE SPRING PROTRUDED. THIS ASSUMPTION IS REINFORCED BY THE CUSTOMER'S LATER STATEMENT: " WITH THIS EMAIL, WE WOULD LIKE TO CANCEL THE NOTIFICATION AND THE REQUESTED INTERVENTION THAT WE SENT YOU IN THE ATTACHMENT, AS AFTER FURTHER CHECKS AND CONSULTATION WITH THE STAFF USING THE DEVICE, IT HAS BEEN ESTABLISHED THAT NO DEFECTS OR DAMAGE TO THE BRONCHOSCOPE OCCURRED DURING THE PROCEDURE. THEREFORE, NO INTERVENTION ON YOUR PART IS REQUIRED." FOR THIS REASON, A USER MISUSE ERROR IS TO BE ASSUMED WHICH LED TO THE DESCRIBED ERROR. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: (B)(4).

Additional Manufacturer Narrative

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

Description of Event or Problem

IT WAS REPORTED THAT THE SUCTION CONNECTOR HAS BEEN BROKEN DURING BRONCHOSCOPY (BROKEN AT THE BASE WHERE IT ATTACHES TO THE BRONCHOSCOPE), CAUSING COMPLETELY THE SPRING INSIDE TO DETACH. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.