Description of Event or Problem · 0
THE USER FACILITY REPORTED A POTENTIAL MYCOBACTERIUM IMMUNOGENUM INFECTION CONCERN ASSOCIATED WITH THE USE OF THE BRONCHOFIBERVIDEOSCOPE. THE DEVICE WAS REPORTEDLY USED DURING A BRONCHOSCOPY PROCEDURE. FOLLOWING THE PROCEDURE, A BRONCHOALVEOLAR LAVAGE (BAL) SPECIMEN COLLECTED FROM THE PATIENT REPORTEDLY IDENTIFIED MYCOBACTERIUM IMMUNOGENUM. THE PATIENT WAS REFERRED TO INFECTIOUS DISEASE FOR FOLLOW-UP. NO PATIENT SYMPTOMS, TREATMENT DETAILS, FINAL DIAGNOSIS, HOSPITALIZATION INFORMATION, OR PATIENT OUTCOME WERE PROVIDED. THE CUSTOMER REPORTED THAT THE PATIENT WAS NOT A CARRIER PRIOR TO THE PROCEDURE. THE CUSTOMER FURTHER REPORTED THAT THE DEVICE UNDERWENT REPROCESSING PER FACILITY PROTOCOL AND WAS SUBSEQUENTLY QUARANTINED FOR EVALUATION. NO DEVICE MALFUNCTION WAS ALLEGED. ADDITIONALLY, NO POSITIVE CULTURE RESULTS FROM THE SUBJECT DEVICE HAVE BEEN REPORTED, AND THE SOURCE OF THE DETECTED MICROORGANISM REMAINS UNDER INVESTIGATION. THE CUSTOMER ALSO INDICATED THAT ENVIRONMENTAL SOURCES ARE BEING EVALUATED AS PART OF THE ONGOING INVESTIGATION. THIS REPORT REPRESENTS 4 OF 17 RELATED PATIENT REPORTS ASSOCIATED WITH THE REPORTED INFECTION CLUSTER.