INNER SHEATH WITH CERAMIC BEAK
Received Oct 4, 2019
Report 9610617-2019-00089 · MDR key 9156869
Device
Generic name
Inner Sheath With Ceramic Beak
Manufacturer
Karl Storz Se & Co. KgModel number
27050CACatalog number
27050CA
Lot number
ZZ01
Product problems
- Material Separation
- Material Separation
Patient
Not reported
- Foreign Body In Patient
- Foreign Body In Patient
Narrative
Additional Manufacturer Narrative
THE DEVICE WAS EVALUATED BY THE MANUFACTURER, KARL STORZ IN (B)(4). AS PER THE EVALUATION: THE CERAMIC TIP IS BROKEN IN ITSELF. HOWEVER, SLIGHT DISCOLORATION DUE TO FIRE DAMAGE IS VISIBLE AT THE DISTAL END. THE CERAMIC TIP HAS BEEN MECHANICALLY OVERLOADED - MOST LIKELY DROPPED WHAT PRE-DAMAGED THE CERAMIC TIP. AN INDICATOR FOR THIS IS THE CRACK FORMATION AT THE CERAMIC TIP. DAMAGES LIKE THIS HAPPEN IF THE CERAMIC INSERT IS HIT AGAINST HARD OBJECTS OR EDGES. DURING INTENDED USE, THERE IS NO POSSIBILITY TO APPLY FORCES TO ACHIEVE THE DEFECTS. THE WARNING NOTICES WITH THE CORRESPONDING PICTURES IN THE IFU INDICATE THIS.
Description of Event or Problem
AS PER A VIGILANCE REPORT FILED BY OUR PARENT COMPANY IN (B)(4), A PART OF THE TIP OF AN INNER SHEATH, ROTATING, WITH CERAMIC INSULATION, CAME OFF DURING INTERVENTION AND GOT LOST IN THE UTERUS. THE BROKEN PIECE WAS REMOVED FROM THE PATIENT.