MalfunctionFBO
INNER CERAMIC INSULATION TUBE
Received Nov 19, 2020 · Event occurred Oct 1, 2020
Report 9610617-2020-00128 · MDR key 10870740
Device
Generic name
Resectoscope Sheath, Inner Fixed Sheath
Manufacturer
Karl Storz Se & Co. KgModel number
27040XBCatalog number
27040XB
Lot number
XX
Product problems
- Material Separation
- Material Separation
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE CERAMIC TIP FRACTURED/BROKE FROM THE SHEATH. THE IMAGES SHOWED THAT A CERAMIC BEAK WAS NEW AND SHINNING AND IN DARK COLOR THAN THE FACTORY ORIGINAL, WHILE THE METAL SHEATH LOOKS AGED AND WITH DENTS. WE BELIEVE THE SHEATH WAS SERVICED BY A THIRD PARTY, AND THE BEAK WAS REPLACED WITH A DIFFERENT CERAMIC MATERIAL.
Description of Event or Problem
ALLEGEDLY, DURING A UROLOGY PROCEDURE, THE CERAMIC TIP OF THE SHEATH BROKE. THE PIECES WERE RETRIEVED, AND THE PROCEDURE WAS COMPLETED.