MalfunctionNGR
CARTILAGE PROBE ASSEMBLY
Received Jun 19, 2006 · Event occurred May 17, 2006
Report 1216828-2006-00029 · MDR key 727122
Device
Product problems
- Peeled/Delaminated
Patient
YR
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
DURING MENISCUS REMOVAL HALF OF THE WHITE PART (PEEL BACK) OF THE TIP OF THE PROBE WAS FOUND MISSING WHEN THE PROBE WAS INSERTED INTO THE KNEE. IT WAS NOT CONFIRMED IF THE PEEL BACK PORTION CAME OFF IN THE PATIENT, NO EXCESSIVE FORCE WAS APPLIED.
Additional Manufacturer Narrative
NO PRODUCT HAS BEEN RETURNED FOR EVALUATION THEREFORE, NO DETERMINATION COULD BE MADE FOR THE REPORTED DEVICE FAILURE. A-4588.