L-CLIP APPL/REMVR 90 MM RND HANDLE VAR
Received Mar 13, 2013 · Event occurred Feb 8, 2013
Report 1045834-2013-00644 · MDR key 3008555
Device
Manufacturer
The Anspach Effort, Inc.Catalog number
45.441
Product problems
- Loss of or Failure to Bond
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
THE DEVICE HAS BEEN RECEIVED BY ANSPACH. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SENT. (B)(4).
Description of Event or Problem
REPORT RECEIVED FROM THE USA STATING THAT THERE WAS A "LOSS OF TENSION" BEING EXPERIENCED IN THE DEVICE AND "WOULD NOT RELEASE THE ANEURYSM CLIP DURING SURGERY." THERE WAS A FIVE MINUTE DELAY IN SURGERY TO REMOVE THE CLIP AND PLACE IT ONTO A NEW APPLIER. THE NEW APPLIER WAS NO MALLEABLE. THE OUTCOME OF THE SURGERY WAS GOOD; CLIPPED THE ANEURYSM WITHOUT A PROBLEM. THERE WERE NO INJURIES OR MEDICAL INTERVENTION REPORTED. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.