MalfunctionDWS
TUNNELER RX1 6 AV-1
Received Apr 17, 2013 · Event occurred Mar 13, 2013
Report 1219977-2013-00027 · MDR key 3070553
Device
Product problems
- Break
Patient
Not reported
- Device Embedded In Tissue or Plaque
Narrative
Description of Event or Problem
TUNNELER INSTRUMENT WAS BROKEN DURING A BYPASS OPERATION. SURGEON HAD TO REMOVE BROKEN PART FROM THE PT'S THIGH.
Additional Manufacturer Narrative
CURRENTLY AWAITING THE RETURN OF THE DEVICE FOR EVAL. A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED BECAUSE THE PRODUCT LOT NUMBER WAS NOT PROVIDED.