MalfunctionFAT
INFRAVISION 60 FR. ESOPHAGEAL KIT (5BX)
Received Oct 25, 2010 · Event occurred Oct 12, 2010
Report 2936485-2010-00789 · MDR key 1885975
Device
Product problems
- Detachment Of Device Component
Patient
UNK
- No Information
Narrative
Description of Event or Problem
IT WAS REPORTED THAT AFTER THE PRODUCT WAS USED IN A PROCEDURE, THE SHEATH ON THE PRODUCT HAD SLIPPED OFF INTO THE STOMACH OF THE PT. IT WAS FURTHER REPORTED THAT THE SHEATH WAS REMOVED FROM THE PT. IT WAS CONFIRMED THAT NO OTHER PARTS REMAINED IN THE PT.
Additional Manufacturer Narrative
ADD'L INFO WILL BE PROVIDED ONCE THE INVESTIGATION IS COMPLETED.