MalfunctionFZG
SINGLE USE ASPIRATION NEEDLE
Received Jul 9, 2014 · Event occurred Jun 11, 2014
Report 8010047-2014-00402 · MDR key 4008997
Device
Generic name
Aspiration Needle
Manufacturer
Olympus Medical Systems CorporationModel number
BA-201SX-4022Catalog number
NA
Product problems
- Break
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
OLYMPUS MEDICAL SYSTEMS CORP (OMSC) WAS INFORMED THAT A PROCEDURE, THE SHEATH WAS KINKED. THERE WAS NO REPORT OF PATIENT INJURY REGARDING THIS EVENT.
Additional Manufacturer Narrative
OMSC HAVE NOT RECEIVED THE SUBJECT PRODUCTS FOR EVALUATION YET. THE EXACT CAUSE OF THE USER'S REPORT COULD NOT BE CONCLUSIVELY DETERMINED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED, IF ADDITIONAL AND SIGNIFICANT INFORMATION BECOMES AVAILABLE AT A LATER TIME. THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IN AN ABUNDANCE OF CAUTION.