MalfunctionHAW
DISPOSABLE REFLECTIVE MARKER SPHERES
Received Nov 5, 2013 · Event occurred Sep 12, 2013
Report 3002743211-2013-00001 · MDR key 3451504
Device
Product problems
- Degraded
- Device Slipped
- Scratched Material
Patient
Not reported
- No Code Available
Narrative
Additional Manufacturer Narrative
NONE.
Description of Event or Problem
NEURO COORDINATOR / MGR AT (B)(6) GENERAL HOSPITAL NOTICED SPHERES WERE "SCUFFED". "THIS HAPPENED A COUPLE OF TIMES DURING A COUPLE DIFFERENT PROCEDURES." THE SPHERES WERE IMMEDIATELY SWITCHED OUT WITH NEW SPHERES RESULTING IN NO ISSUE WITH THE PT AND NO MEANINGFUL DELAY TO THE PROCEDURE ITSELF. "LIKE MAYBE A MINUTE" DELAY OR THE TIME IT TAKES TO REPLACE A SPHERE. NO SERIOUS IMPLICATIONS TO THE ISSUE MENTIONED. IT WAS ALSO REMARKED THERE WERE ISSUES WITH SPHERES STRIPPING AND NOT STAYING ON THEIR POSTS.