NDI PASSIVE SPHERES
Received Jul 20, 2015 · Event occurred Jun 19, 2015
Report 3002743211-2015-00040 · MDR key 4925055
Device
Product problems
- Positioning Problem
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
DEVICE RETURNED WRAPPED IN SURGICAL GLOVE. INDICATES THAT THE DEVICE WAS USED IN A SURGERY AND BIOHAZARDOUS, NOT DECONTAMINATED. DEVICE CAN NOT BE SAFELY EVALUATED BASED ON CONDITION IT WAS RECEIVED IN.
Description of Event or Problem
THIS EVENT WAS COMMUNICATED BY A CUSTOMER REPRESENTATIVE WHO REPORTED THAT A SITE ((B)(6)) HAD SPHERES THAT DID NOT TRACK. SITE REPLACED SPHERES AND THE NEW SPHERES WERE ABLE TO TRACK. LOT NUMBER IS UNKNOWN, BUT BASED ON PAST SALES COULD BE 1502141, 1502051 OR 1503111. COMPLAINANT REPORTED THAT THERE WAS NO PATIENT/USER INJURY, DEATH OR OTHER SERIOUS DETERIORATION IN HEALTH.