MalfunctionFBO
INNER SHEATH ONLY
Received Dec 16, 2020
Report 9610617-2020-00145 · MDR key 11021695
Device
Product problems
- Material Integrity Problem
- Material Integrity Problem
Patient
Not reported
- Foreign Body In Patient
- Patient Problem/Medical Problem
- Foreign Body In Patient
- Patient Problem/Medical Problem
Narrative
Additional Manufacturer Narrative
ITEM WAS FOUND THE BEAK WAS BROKEN AND MISSING THE STOPCOCK MANIFOLD. THIS TYPE OF OCCURRENCE MOST LIKELY IS RELATED TO MECHANICAL FORCE.
Description of Event or Problem
ALLEGEDLY, THE CERAMIC DISTAL TIP OF THE INNER SHEATH BROKE OFF INTO THE PATIENT'S BLADDER AND WAS SUCCESSFULLY RETRIEVED.