PROBE, DOPPLER
Received May 10, 2016 · Event occurred Jan 26, 2016
Report 2921578-2016-00008 · MDR key 5644865
Device
Product problems
- Break
- Device Inoperable
- Device Operates Differently Than Expected
Patient
30 YR
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
THE USER FACILITY REPORT IDENTIFIED MIZUHO OSI AS THE MANUFACTURER, BUT MIZUHO OSI DOES NOT PRODUCE DOPPLER PROBES.
Description of Event or Problem
THE DOPPLER PROBE WAS NOT WORKING DURING THE SURGICAL PROCEDURE. NO SOUND WAS HEARD. NO INJURY OCCURRED TO THE PATIENT. WHAT WAS THE ORIGINAL INTENDED PROCEDURE? ENDOSCOPIC TRANSSPHENOIDAL HYPOPHYSECTOMY DEVICE USAGE PROBLEM: DEVICE FAILED (E.G. BROKE, COULDN'T GET IT TO WORK OR STOPPED WORKING).