MalfunctionEMF
STRATOS
Received Oct 20, 2014 · Event occurred Aug 5, 2014
Report 2437731-2014-00001 · MDR key 4195268
Device
Product problems
- Detachment Of Device Component
- Mechanical Problem
Patient
58 YR
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
.
Description of Event or Problem
WHILE INSERTING SCOPE INTO DEVICE, MANIPULATED THE DEVICE SIDE TO SIDE AND ATTEMPTED TO DEPLOY BLADE. BLADE POPPED OFF.
Remedial action
- Other