NDI PASSIVE MARKER SPHERES
Received Feb 11, 2016 · Event occurred Dec 16, 2015
Report 3002743211-2016-00002 · MDR key 5431975
Device
Product problems
- Improper or Incorrect Procedure or Method
- Component Missing
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
AS NOTED, THE SITE HAS BEEN USING STERILE SPHERES MULTIPLE TIMES. THE RE-USE OF SPHERES MAY HAVE CONTRIBUTED TO THE SPHERE COMING OFF THE POST UN-NOTICED. DEVICE DISCARDED BY SITE.
Description of Event or Problem
DURING PROCEDURE, SITE (EL CAMINO SURGERY CENTER) INDICATED THAT THEY WERE MISSING A SPHERE. INITIALLY UNSURE IF THE SPHERE WAS LEFT IN PATIENT, DROPPED ON FLOOR OR DISPOSED OF. THE PROCEDURE WAS COMPLETED AND NO DELAY WAS REPORTED. THERE WAS NO IMPACT ON PATIENT OUTCOME. SITE EVENTUALLY REPORTED THAT THE SPHERE WAS FOUND OUTSIDE OF THE SURGERY. SITE ALSO CONFIRMED THAT THE SPHERES WHICH ARE SINGLE-USE WERE RE-USED MULTIPLE TIMES PREVIOUSLY.