MalfunctionIWG
INSTANT LINK MAGAZINE
Received Apr 9, 2010 · Event occurred Mar 23, 2010
Report MW5015517 · MDR key 1658752
Device
Product problems
- Positioning Failure
- Defective Device
Patient
61 YR
- No Information
Narrative
Description of Event or Problem
INSTANT LINK SEED CARTRIDGE HAD A PRODUCT DEFECT THAT DID NOT ALLOW ALL OF THE SEEDS TO BE RELEASED FROM THE CARTRIDGE FOR IMPLANTATION. THIS RESULTED IN INCREASED OPERATING ROOM TIME AND ANESTHETIC. SEED IMPLANTATION, DISCOVERY OF PROBLEM AND INFORMATION PROVIDED (B) (6).