ECHO LUMENA
Received Mar 22, 2026 · Event occurred Feb 13, 2026
Report 1034569-2026-00012 · MDR key 24658804
Device
Product problems
- Protective Measures Problem
Patient
NA · Female
- Pain
Narrative
Description of Event or Problem
ON FEBRUARY 20, 2026 A CUSTOMER REPORTED THAT TECHNICIAN WAS INJURED WHILE REPLACING THE SYRINGE OF ECHO LUMENA INSTRUMENT SERIAL NUMBER (B)(6). CUSTOMER HAS STATED THAT THE EVENT WAS REPORTED FOR DOCUMENTATION PURPOSES ONLY.
Additional Manufacturer Narrative
NO INJURY FOLLOW UP WAS PROVIDED BY THE CUSTOMER. NO SERIOUS OR PERMANENT INJURY OR HARM WAS REPORTED RELATED TO INSTRUMENT MALFUNCTION. THE SPECIFIC INSTRUMENT WAS INSPECTED FOR POTENTIAL DEFECTS OF THE FLUIDICS MODULE COVER AND HINGE ASSEMBLY BY CUSTOMER AFTER THE EVENT AND WAS FOUND TO BE WORKING AS EXPECTED. NO SPECIFIC INSTRUMENT DEFECT OR MALFUNCTION WAS IDENTIFIED. THERE HAVE BEEN NO EVENTS OF A SIMILAR NATURE REPORTED FOR THE ECHO LUMENA INSTRUMENT. THERE IS NO SPECIFIC ACTION THAT USERS ARE EXPECTED TO TAKE TO MITIGATE THE REPORTED DEVICE FAILURE/MALFUNCTION OTHER THAN TO ENSURE THAT PREVENTATIVE MAINTENANCE IS PERFORMED AS INDICATED IN THE INSTRUMENT INSTRUCTIONS. THE IMMUCOR INTERNAL REFERENCE NUMBER FOR THIS EVENT IS PR # (B)(4).