MalfunctionGAS
ULTRA FAST-FIX AB ASSY. CURVED
Received Sep 23, 2009 · Event occurred Aug 20, 2009
Report 1219602-2009-00251 · MDR key 1504177
Device
Generic name
Ultra Fast-fix Ab Assy. Curved / Gat
Manufacturer
Mansfield Manufacturing SiteModel number
72201494Catalog number
72201494
Lot number
50293838
Product problems
- Positioning Failure
- 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
T1 DEPLOYED AFTER MULTIPLE ATTEMPTS, T2 WOULD NOT DEPLOY EVEN WITH FORCE AFTER THE T AND DELIVERY DEVICE WERE REMOVED FROM THE OPERATIVE SITE. NON ABSORBABLE FAST FIX USED IN PLACE OF AN ABSORBABLE.
Additional Manufacturer Narrative
DEVICE IS NOT BEING RETURNED FOR EVALUATION. (B) (4)