INTUBATION LARYNGOSCOPE
Received Dec 30, 2016 · Event occurred Dec 19, 2016
Report 6216247 · MDR key 6216247
Device
Generic name
Laryngoscope, Non-rigid
Manufacturer
Karl Storz Endoscopy-america, Inc.Model number
11301BN1Catalog number
11301BN1
Product problems
- Failure to Select Signal
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
DURING AN ATTEMPT TO INTUBATE A PATIENT THE DIGITAL VIDEO INTUBATION SCOPE WOULD NOT REGISTER OR PROVIDE AN IMAGE WHEN ANESTHESIOLOGIST PLUGGED DEVICE INTO THE SCOPE MONITOR PORT. AFTER SEVERAL ATTEMPTS THE SCOPE WAS EXCHANGE FOR A FIBER OPTIC INTUBATION SCOPE AND THE PATIENT WAS INTUBATED AND CASE PROCEEDED. THERE WAS NOT PATIENT HARM IN THIS EVENT. SCOPE CLEANED AND SENT TO BIOMEDICAL FOR EVALUATION. THIS WAS THE SECOND EVENT THIS WEEK ON THESE DIGITAL SCOPES FAILING PRIOR TO USE. BIOMEDICAL INCLUDING A SECOND SCOPE IN THIS REPORT FOR MANUFACTURER EVALUATION AND REPORT. MANUFACTURER RESPONSE FOR DIGITAL VIDEO INTUBATION SCOPE, STORZ ENDOSCOPE (PER SITE REPORTER): MANUFACTURER STANDARD RESPONSE IS TO SEND IN FOR REPAIR EVALUATION. BIOMEDICAL TO REQUEST FORMAL REPORT. MANUFACTURER RESPONSE FOR DIGITAL VIDEO INTUBATION SCOPE, (BRAND NOT PROVIDED) (PER SITE REPORTER): STANDARD MFG RESPONSE OF SENDING IN UNIT FOR REPAIR COST EVALUATION. BIOMEDICAL REQUESTING FORMAL REPORT.