FIBERSCOPE, CYSTO-URETHRO, US DEFLECTION

Additional Manufacturer Narrative

THE EVALUATION FOUND AN OVERBEND IN THE PROXIMAL SHAFT; THE CHANNEL WALL WAS LIFTED, NO LEAK; DEBRIS WAS FOUND ON THE VERTEBRAE; AND BROKEN IMAGE AND LIGHT FIBERS. OUR FIELD SERVICE SPECIALIST PERFORMED AN IN-SERVICE AND FOUND SEVERAL AREAS FOR PROCESS IMPROVEMENTS WITHIN THE FACILITY THAT WILL HELP THEM WITH INFECTION CONTROL IN THE FUTURE. THE POTENTIAL PATIENT INFECTIONS WERE IDENTIFIED BUT NOT CAPTURED IN OUR SYSTEM UNTIL AFTER RECEIPT OF THE FLEXIBLE SCOPE FROM THE CUSTOMER. THEREFORE, A MICROBIOLOGICAL ASSESSMENT WAS NOT PERFORMED UPON RECEIPT.

Description of Event or Problem

ALLEGEDLY, THERE WERE REPORTED PATIENT INFECTIONS AFTER THE USE OF OUR FLEXIBLE FIBERSCOPE DURING PROCEDURES.