KARL STORZ SE & CO. KG INNER CERAMIC INSULATION TUBE; RESECTOSCOPE SHEATH, INNER FIXED SHEATH
|
Back to Search Results |
|
Model Number 27040XB |
Device Problem
Material Separation (1562)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 10/01/2020 |
Event Type
malfunction
|
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.
|
|
Event Description
|
Allegedly, during a urology procedure, the ceramic tip of the sheath broke.The pieces were retrieved, and the procedure was completed.
|
|
Search Alerts/Recalls
|
|
|