INNER CERAMIC INSULATION TUBE
Received Apr 12, 2022 · Event occurred Mar 9, 2022
Report 9610617-2022-00031 · MDR key 14084349
Device
Generic name
Resectoscope Sheath, Inner Fixed Sheath
Manufacturer
Karl Storz Se & Co. KgModel number
27040XBCatalog number
27040XB
Lot number
NV01
Product problems
- Break
- Material Separation
- Break
- Material Separation
Patient
Male
- Foreign Body In Patient
- Foreign Body In Patient
Narrative
Additional Manufacturer Narrative
THE CERAMIC TIP FRACTURED/BROKE FROM THE SHEATH AT END OF PROCEDURE WHEN PULLING OUT INSTRUMENT. A MISSING PIECE IS STILL IN PATIENT. THE SHEATH IS OVER 8 YEARS OLD.
Description of Event or Problem
DURING A TURP, SURGEON COMPLETED THE SURGERY, AND REALIZED WHEN PULLING OUT THE INSTRUMENTS THAT A BROKEN PIECE OF CERAMIC CAME OUT. A MISSING PIECE IS STILL IN THE PATIENT.
Additional Manufacturer Narrative
AN INVESTIGATION REPORT FROM KST/MFR. WAS RECEIVED WHICH STATES: THE CONCLUSION AND ROOT CAUSE OF THE NON-RETURN PRODUCT: "THE MOST LIKELY CAUSE IS THE AGE ( 8 YEARS) OF THE ITEM AND THE HIGH" APPLICATION CYCLES. THIS PROBABLY CAUSED MICRO CRACKS ON THE CERAMIC BEAK, WHICH LED TO THE BREAKAGE OF THE BEAK DURING EXTRACTION.