MalfunctionNKS
TAPERTOME
Received Jun 7, 2006 · Event occurred May 12, 2006
Report 6000048-2006-00262 · MDR key 723376
Device
Generic name
Cannulating
Manufacturer
Boston Scientific SpencerModel number
*Catalog number
3282
Lot number
8225668
Product problems
- Replace
- Wire(s), breakage of
Patient
*
- Unknown (for use when the patient's condition is not known)
Narrative
Description of Event or Problem
A TAPERTOME WAS GOING TO BE USED FOR A THERAPEUTIC ERCP. BEFORE THE PROCEDURE, WHILE OPENING THE PACKAGE, THE CUTTING WIRE BROKE. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE.