FLEXIBLE VIDEO URETRHO-CYSTOSCOPE

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

THE FOLLOWING WAS REPORTED: "THE PATIENT REQUIRED ELECTRONIC NASOPHARYNGOLARYNGOSCOPY DUE TO NASOPHARYNGOLARYNGEAL DISCOMFORT. AFTER HEALTHCARE STAFF STRICTLY FOLLOWED OPERATIONAL PROTOCOLS TO CALIBRATE THE EQUIPMENT AND COMPLETE DISINFECTION PREPARATIONS, THEY INITIATED THE ELECTRONIC NASOPHARYNGOLARYNGOSCOPE TO PERFORM EXAMINATION AND TREATMENT. DURING THE PROCEDURE, THE DEVICE FREQUENTLY EXHIBITED SCREEN FLICKERING, UNSTABLE IMAGING, AND INTERMITTENT FREEZING, SEVERELY INTERFERING WITH THE PHYSICIAN'S INTRAOPERATIVE VISUAL FIELD OBSERVATION AND ACCURATE LESION ASSESSMENT. HEALTHCARE STAFF WERE FORCED TO REPEATEDLY ADJUST THE EQUIPMENT, DIRECTLY PROLONGING THE PROCEDURE DURATION, INCREASING THE PHYSICIAN'S OPERATIONAL DIFFICULTY AND WORKLOAD, AND EXACERBATING THE PATIENT'S INTRAOPERATIVE DISCOMFORT, PSYCHOLOGICAL STRESS, AND TOLERANCE BURDEN, THEREBY AFFECTING THE SMOOTHNESS OF THE DIAGNOSTIC AND THERAPEUTIC PROCESS AND THE PATIENT'S EXPERIENCE." NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.