MalfunctionGBW
TAUT INTRADUCERS 8RF
Received Jun 3, 2011 · Event occurred May 23, 2011
Report 3003898360-2011-00261 · MDR key 2158598
Device
Product problems
- Break
Patient
UNK
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
THE EVENT IS REPORTED AS: ALLEGED ISSUE: TIP OF SHEATH BROKE OFF INSIDE THE PATIENT WHILE PERFORMING THE PROCEDURE. ALL THE PIECES WERE RETRIEVED, INCLUDING THE TIP, AND ANOTHER DEVICE WAS USED WITH NO FURTHER ISSUES. NO PATIENT INJURY REPORTED.
Additional Manufacturer Narrative
SAMPLE HAS BEEN RECEIVED BY MANUFACTURER BUT INVESTIGATION IS INCOMPLETE AT TIME OF THIS REPORT. A FOLLOW UP REPORT WILL BE SENT WHEN INVESTIGATION IS COMPLETE.
Remedial action
- Other