MalfunctionFDX
URETERAL BRUSH BIOPSY SET
Received Nov 28, 2018 · Event occurred Mar 7, 2015
Report 1820334-2018-03564 · MDR key 8111133
Device
Product problems
- Unraveled Material
- Material Twisted/Bent
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
THIS MDR IS BEING FILED AFTER THE ASSOCIATED COMPLAINT WAS REVIEWED UNDER REMEDIATION PROTOCOL (B)(4), COMPLAINT/MDR RETROSPECTIVE REVIEW AND REMEDIATION AND REASSESSED AS REPORTABLE. ADDITIONAL COMPLAINT INVESTIGATION AND RECORD REMEDIATION WAS NOT PERFORMED.
Description of Event or Problem
IT WAS REPORTED THAT WHEN THE USER OPENED THE PACKAGE, IT WAS NOTED THAT THE TIP OF URETERAL BRUSH WAS BENT. IT WAS FURTHER NOTED THAT THE COIL HAD BEEN UNWOVEN AND WAS IN A DAMAGED STATE. ANOTHER DEVICE WAS USED INSTEAD, AND THE PROCEDURE WAS COMPLETED.