MalfunctionNTB
ULTRAWAND LP
Received Dec 27, 2010
Report 3003870001-2010-00015 · MDR key 1961590
Device
Generic name
Ultrawand Lp
Manufacturer
St. Jude MedicalModel number
12400Catalog number
12400
Lot number
NA
Product problems
- Ambient Noise Problem
Patient
UNK
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
IT WAS REPORTED THE DEVICE WAS POPPING AND HISSING DURING USE. THERE WERE NO REPORTED PATIENT CONSEQUENCES.
Additional Manufacturer Narrative
WE ARE IN THE PROCESS OF EVALUATING THIS DEVICE. WHEN OUR INVESTIGATION IS COMPLETE, A FOLLOW-UP REPORT WILL BE SUBMITTED. (B)(4).