VANGUARD BREAST MRI AUXILLIARY TABLE WITH 8 CH
Received Nov 27, 2010 · Event occurred Oct 21, 2010
Report 3005748597-2010-00002 · MDR key 1929795
Device
Product problems
- Insufficient Device Problem Information
Patient
Not reported
- Full thickness (Third Degree) Burn
Narrative
Description of Event or Problem
ONE PT UNDERWENT A BREAST MRI EXAM USING THE SENTINELLE BREAST COIL, GE SIGNA 1.5T MRI SCANNER, AND SENORX 7-GAUGE BIOPSY NEEDLE. PT RETURNED TO THE EMERGENCY DEPARTMENT THREE (3) DAYS POST PROCEDURE FOR TREATMENT OF TWO 3RD DEGREE BURNS. ONE (1) BURN WAS APPROX A QUARTER-SIZE AND SITUATED JUST BELOW THE INCISION. OTHER (2) BURNS WERE SITUATED ABOVE THE BIOPSY INCISION AND WAS PIN-HEAD IN SIZE. SITE REPORTED USING THEIR SYSTEM SINCE THE INCIDENT WITHOUT ANY ADVERSE EVENTS, PROBLEMS, OR FAILURES. SENTINELLE SERVICE PERSONNEL, DISPATCHED TO SITE TO INVESTIGATE, INSPECT AND TEST THE AFFECTED BREAST COILS TO DETERMINE ANY ASSOCIATION BETWEEN THE DEVICE AND THE EVENT.
Additional Manufacturer Narrative
THE DEVICE WAS INSPECTED BY SENTINELLE SERVICE PERSONNEL POST EVENT. NO COMPONENT OR SYSTEM FAULTS WERE IDENTIFIED DURING THE INSPECTION. DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED ON THE IDENTIFIED (B)(4). NO FAILURES OR ABNORMALITIES WERE FOUND RELATED TO THE REPORTED INFO. THE DEVICE PASSED FINAL TEST AND INSPECTION PRIOR TO RELEASE. THERE IS NO KNOWN ASSOCIATION BETWEEN THE EVENT AND THE DEVICE. RESULTS: NO FOREIGN SUBSTANCES OR AMOUNTS OF BLOOD FOUND ANYWHERE ON COILS OR FRAMES. SUMMARY: THE PRODUCT PERFORMED AS INTENDED DURING INSPECTION AND TESTING. NO FOREIGN SUBSTANCES OR AMOUNTS OF BLOOD WERE FOUND ANYWHERE ON COILS OR FRAMES. THE REPORTED COMPLAINT AND ADVERSE EVENT CANNOT BE CONFIRMED. THIS OBSERVATION WILL BE MONITORED AND TRENDED.