KARL STORZ

Description of Event or Problem

DURING INTUBATION PROCEDURE, THE SCOPE SUDDENLY LOST IMAGE. PROCEDURE WAS COMPLETED WITH ALTERNATE EQUIPMENT. NO PATIENT INJURY OCCURRED BUT THERE WAS A SLIGHT DELAY IN THE PROCEDURE. EVALUATION OF THE SCOPE INDICATES FLUID HAD INGRESSED TO THE CIRCUITRY INSIDE THE SCOPE. WE HAVE HAD 6 SIMILAR FAILURES WITH THIS MODEL IN THE PAST 2 WEEKS OR SO. THE DEVICE IS MARKED IPX8, WHICH INDICATES IT SHOULD BE ABLE TO SURVIVE COMPLETE SUBMERSION TO OVER 1M WITHOUT DAMAGE. THE DEVICES ARE NOT MEETING THIS SPECIFICATION. FLUID INGRESS OCCURS DURING THE CLEANING AND DISINFECTION PROCESS.======================MANUFACTURER RESPONSE FOR KARL STORZ VIDEO LARYNGOSCOPE (PER SITE REPORTER).======================SEVERAL UNITS HAVE BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. MANUFACTURER HAS SUGGESTED USING STERRAD FOR PROCESSING INSTEAD OF SOAKING IN OPA. EVALUATION RESULTS ARE PENDING.