INNER SHEATH ONLY
Received Dec 29, 2020 · Event occurred Nov 30, 2020
Report 9610617-2020-00147 · MDR key 11089238
Device
Product problems
- Material Fragmentation
- Material Integrity Problem
- Material Fragmentation
- Material Integrity Problem
Patient
Not reported
- Foreign Body In Patient
- Patient Problem/Medical Problem
- Foreign Body In Patient
- Patient Problem/Medical Problem
Narrative
Additional Manufacturer Narrative
THE ITEM IS FOUND THE CERAMIC BEAK IS BROKEN OFF THE END OF THE DISTAL SHAFT. THE SHAFT HAS A DENT APPROXIMATELY MIDWAY AND ANOTHER NEAR THE DISTAL END. THE DISTAL END OF THE SHEATH HAS A JAGGED EDGE WHERE THE BEAK HAD BROKEN OFF. THE SHEATH HAS STAINING ON THE INSIDE AND OUTSIDE. THE INSTRUMENT HAS GENERAL WEAR AND TEAR. THIS TYPE OF OCCURRENCE MOST LIKELY IS RELATED TO MECHANICAL FORCE.
Description of Event or Problem
ALLEGEDLY, WHILE PERFORMING A TRANSURETHRAL RESECTION OF PROSTATE (TURP), THE CERAMIC TIP BROKE OFF IN PATIENT'S URETHRA WHEN THE RESECTOSCOPE WAS BEING REMOVED FROM PATIENT. THIS CAUSED TRAUMA AND BLEEDING TO THE URETHRA. NO FURTHER INFORMATION IS AVAILABLE.