MalfunctionGAS
ULTRA FAST-FIX CURVED
Received Jul 29, 2009 · Event occurred May 15, 2009
Report 1219602-2009-00218 · MDR key 1491573
Device
Product problems
- Device, or device fragments remain in patient
Patient
Not reported
- Unknown (for use when the patient's condition is not known)
Narrative
Description of Event or Problem
THE SECOND TOGGLE DID NOT DEPLOY AFTER PUSHING THE GOLD BUTTON DOWN. THERE WAS ONE TOGGLE FROM EACH FAILED IMPLANT THAT WAS LEFT OUTSIDE OF THE CAPSULE.
Additional Manufacturer Narrative
DEVICE IS NOT BEING RETURNED FOR EVALUATION.