MalfunctionHAW
NDI PASSIVE SPHERES
Received Sep 18, 2015 · Event occurred Aug 11, 2015
Report 3002743211-2015-00051 · MDR key 5087741
Device
Product problems
- Device Sensing Problem
Patient
Not reported
- No Patient Involvement
Narrative
Additional Manufacturer Narrative
DEVICE DISCARDED BY SITE.
Description of Event or Problem
THIS EVENT WAS COMMUNICATED BY A MEDTRONIC (B)(4) REPRESENTATIVE FROM HOSPITAL (B)(6). IN STERILE FIELD, THE DEVICE (SPHERES) WAS NOT RECOGNIZED. SO, THE TEAM CHANGED THE SPHERES AND EVERYTHING WORKED WELL. COMPLAINANT NOTED THAT THIS ISSUE DID NOT INVOLVE A PATIENT. THEREFORE NO SERIOUS INJURY OR ADVERSE EVENT TO A PATIENT. DEVICE WAS NOT RETURNED. EXCEPT WHEN ROTATED. COMPLAINANT REPORTED THAT THERE WAS NO PATIENT/USER INJURY, DEATH OR OTHER SERIOUS DETERIORATION IN HEALTH.