MalfunctionGDF
GHIATAS LOCALIZATION WIRE
Received Oct 16, 2019
Report 2020394-2019-04035 · MDR key 9200115
Device
Generic name
Biopsy Instrument
Manufacturer
Bard Peripheral Vascular, Inc.Model number
475201Catalog number
475201
Lot number
REDQ0895
Product problems
- Signal Artifact/Noise
- Signal Artifact/Noise
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL 475201 BIOPSY INSTRUMENT ALLEGEDLY HAD SIGNAL ARTIFACT ON MRI IMAGING. THERE WAS NO REPORTED PATIENT INJURY. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. PATIENT AGE, WEIGHT, AND GENDER WERE NOT PROVIDED.