FIVE S 3.5X65, STERILE, FOR SINGLE USE,

Additional Manufacturer Narrative

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

Description of Event or Problem

IT WAS REPORTED THAT DURING PROCEDURE WHILE INTUBATING THE PATIENT USING THE FIVE S, THEY DEFLECTED THE SCOPE AND COULDN'T PUT IT BACK IN THE RIGHT POSITION. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED. FURTHER INFORMATION HAS BEEN RECEIVED ON JUNE 24, 2025. THE FOLLOWING WAS REPORTED: DURING THE PROCEDURE, AFTER SUCCESSFUL ENTRY INTO THE TRACHEA WITH THE BRONCHOSCOPE AND ADVANCING THE ENDOTRACHEAL TUBE OVER IT, WE ATTEMPTED TO WITHDRAW THE BRONCHOSCOPE FROM THE ETT (ENDOTRACHEAL TUBE). UNFORTUNATELY, WE WERE UNABLE TO DO SO. DESPITE MULTIPLE ATTEMPTS AND MANIPULATION OF THE CONTROL LEVER IN BOTH UPWARD, DOWNWARD, AND NEUTRAL POSITIONS, THE BRONCHOSCOPE REMAINED LOCKED IN A FIXED CURVED CONFIGURATION. THIS CREATED A HIGHLY CHALLENGING SITUATION. AFTER SEVERAL FORCEFUL ATTEMPTS, WE WERE EVENTUALLY ABLE TO REMOVE THE ENTIRE UNIT, BRONCHOSCOPE AND ETT TOGETHER WITHOUT CAUSING HARM TO THE PATIENT. HOWEVER, THIS NECESSITATED THE EXTUBATION OF A DIFFICULT AIRWAY, AND WE HAD TO REINTUBATE THE PATIENT USING AN ALTERNATIVE APPROACH. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED. HOWEVER, DUE TO THE REPORTED UNPLANNED REINTUBATION, THIS CASE IS DEEMED REPORTABLE.

Additional Manufacturer Narrative

RESULT OF INVESTIGATION: AS THE DEVICE HAS NOT BEEN SENT BACK FOR INVESTIGATION, A FINAL DETERMINATION OF THE ROOT CAUSE IS NOT POSSIBLE. SIMILAR COMPLAINTS ON DIFFERENT SINGLE USE ENDOSCOPES HAD A VARIETY OF ROOT CAUSES FOR THE MALFUNCTION, SUCH AS: BROKEN ARTICULATION. RUPTURED STEERING WIRES - BOTH CAUSED BY EXCESSIVE FORCE. THE ABOVE 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 DEVICE'S MANUFACTURING RECORDS. THE LABELLING WAS FOUND TO CONTAIN ADEQUATE INSTRUCTIONS AND WARNINGS. THE COMPLAINT HISTORY DID NOT REVEAL ANY PICKUP IN SIMILAR COMPLAINTS; NO TREND WAS IDENTIFIED. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: (B)(4).