NDI PASSIVE SPHERES
Received Jul 11, 2014 · Event occurred Jan 21, 2011
Report 3002743211-2014-00001 · MDR key 4170682
Device
Generic name
Reflective Passive Marker Sphere - Haw, Olo
Manufacturer
Northern Digital, Inc.Lot number
4797801
Product problems
- Device Misassembled During Manufacturing /Shipping
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
OPERATING ROOM STAFF AT (B)(6) NOTED A PASSIVE MARKER SPHERE HAD DELAMINATED REFLECTIVE FILM. THIS WAS NOTED DURING A PROCEDURE. AS SPHERE WAS USED DURING A PROCEDURE IT WAS DESTROYED VIA AUTOCLAVE AS IT WAS USED IN A PROCEDURE AND CONSIDERED A BIOHAZARD. DURING INVESTIGATION IT WAS DETERMINED THAT THE ADHESIVE FOR THE FILM WAS IMPROPERLY APPLIED. THIS ISSUE WAS CORRECTED AND THIS FAILURE HAS NOT RECURRED SINCE THIS REPORT. NO SERIOUS IMPLICATIONS TO THIS ISSUE WERE MENTIONED BY THE COMPLAINANT. NO PT WAS HARMED AND NO SERIOUS INJURY OCCURRED.