MalfunctionFEO
PROBE,STERILE, ULTRASONIC OSCILLATING
Received Apr 22, 2019 · Event occurred Feb 12, 2019
Report 9610617-2019-00039 · MDR key 8538148
Device
Generic name
Oscillating Sterile Probe
Manufacturer
Karl Storz Se & Co. KgModel number
27093LKLot number
51791
Product problems
- Break
Patient
Not reported
- Foreign Body In Patient
- Patient Problem/Medical Problem
- Foreign Body In Patient
- Patient Problem/Medical Problem
Narrative
Additional Manufacturer Narrative
CUSTOMER HAS NOT RETURNED PRODUCT 27093LK AND HAS NOT RESPONDED TO OUR ATTEMPTS TO GATHER FURTHER INFORMATION. THE STERILE ULTRASONIC OSCILLATING PROBE WAS SHIPPED TO THE CUSTOMER APPROXIMATELY 3 YEARS AGO.
Description of Event or Problem
ALLEGEDLY, THE ITEM BROKE IN TWO PIECES IN THE PATIENT DURING A PROCEDURE. THEY WERE ABLE TO RETRIEVE ALL BROKEN PIECES AND IT WAS REPORTED THERE WAS NO HARM TO THE PATIENT.