MalfunctionFBO
TUBE,INNER,CERAMIC INSULATION
Received Oct 16, 2019 · Event occurred Aug 21, 2019
Report 9610617-2019-00098 · MDR key 9200073
Device
Product problems
- Break
Patient
Not reported
- Patient Problem/Medical Problem
- Patient Problem/Medical Problem
Narrative
Additional Manufacturer Narrative
MEDWATCH #MW5089606 DOES NOT HAVE A FACILITY NAME, ADDRESS OR CONTACT INFORMATION PROVIDED. WE SEARCHED OUR DATA BASE AND DO NOT SEE ANY RETURNING ORDERS, WHICH FIT THIS CRITERIA, THEREFORE WE CANNOT GATHER FURTHER INFORMATION. IN ADDITION, THIS MODEL OF SHEATH HAS A CERAMIC BEAK AT THE DISTAL END, NOT "PLASTIC" END. WE DO NOT KNOW IF THE INSTRUMENT HAS BEEN REPAIRED BY A 3RD PARTY AND REPLACED THE BEAK MATERIAL.
Description of Event or Problem
PER MEDWATCH REPORT, #MW5089606 RECEIVED ON (B)(6) 2019, IT WAS REPORTED THE "PLASTIC END PIECE OF INSTRUMENT BROKE DURING A PROCEDURE".