MalfunctionMAM
MAMMOTOME EX PROBE AND ACUUM SET
Received Nov 19, 2009 · Event occurred Oct 22, 2009
Report 3005075853-2009-07127 · MDR key 1534482
Device
Generic name
Mammotome Ex Probe And Vacuum Set
Manufacturer
Ethicon Endo-surgery, Llc.Model number
UNKCatalog number
HH8BEX
Lot number
F4P88H
Product problems
- Failure to Obtain Sample
Patient
Not reported
- No Information
Narrative
Description of Event or Problem
IT WAS REPORTED THAT DURING A BREAST BIOPSY THE PHYSICIAN KEPT ATTEMPTING TO TAKE SAMPLES AND WAS NOT RETREIVING ANY. THEY CHANGED PROBES AND CONTINUED TO HAVE THE ISSUE. THEY SWITCHED TO THE VACORA SYSTEM AND FINISHED THE CASE.
Additional Manufacturer Narrative
(B) (4). (B) (4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.