LEICA BIOSYSTEMS CYTOVISION GSL
Received Jan 30, 2024 · Event occurred Jan 4, 2024
Report 1419341-2024-00001 · MDR key 18609706
Device
Product problems
- Loss of or Failure to Bond
- Loss of or Failure to Bond
Patient
Unknown
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
Narrative
Description of Event or Problem
ON 04 JAN 2024 THE CUSTOMER HAS REPORTED THE GLUE FAILED ON THE MAGNENT IN THE TRAY, MATERIAL 23GSL902XXX001, WHICH RESULTED IN BREAKING FIVE (5) BONE MARROW SLIDES FOR ONE (1) PATIENT WHILE USING CYTOVISION, MATERIAL 23GSLXXXKFXUPG, SERIAL (B)(6). THERE WAS TISSUE LOSS. IT IS UNKNOWN IF RE-BIOPSY WAS REQUIRED.
Additional Manufacturer Narrative
A DEVICE HISTORY REVIEW WAS COMPLETED. THERE WERE NO DEVIATIONS OR NON-CONFORMANCES ASSOCIATED WITH THIS SERIAL NUMBER. TRENDING ANALYSIS REPORTED NO (0) OTHER RELATED OCCURRENCES OF THIS ISSUE FOR THIS SERIAL NUMBER. THE CYTOVISION WAS CLEANED AND A NEW TRAY WAS LOADED INTO THE SYSTEM AND FUNCTIONED AS EXPECTED. IF ADDITIONAL INFORMATION IS RECEIVED AN ADDITIONAL FOLLOW UP MDR WILL BE SUBMITTED.