700-SERIES
Received Jul 17, 2026 · Event occurred Jun 16, 2026
Report 3013876692-2026-00089 · MDR key 25857310
Device
Generic name
Sterilizer, Steam
Manufacturer
Getinge Ic Production Poland Sp. Z O.o.Model number
733HC-ECatalog number
7LLVUPHTAAAA
Product problems
- Detachment of Device or Device Component
Patient
NA · Unknown
- Bone Fracture(s)
Narrative
Description of Event or Problem
GETINGE BECAME AWARE OF AN INCIDENT INVOLVING MISSING PARTS ON A CART USED WITH THE 733HC-E STEAM STERILIZER, WHICH CAUSED AN INJURY TO STAFF. FURTHER COMMUNICATION PROVIDED MORE DETAILED CLARIFICATION OF THE EVENT: THE RACK WAS NOT ALIGNED WITH THE STERILIZER TRACK. THE EMPLOYEE ATTEMPTED TO LIFT THE CART BACK ONTO THE TRACK USING THE PULL HANDLE. HOWEVER, THE HANDLE WAS NOT SECURED AS IT WAS MISSING SCREWS/BOLTS TO HOLD IT IN PLACE. THE PULL HANDLEBAR CAME OFF, HITTING THE EMPLOYEE IN THE FACE. THE EMPLOYEE WENT TO THE ER, HAS SUFFERED A BROKEN NOSE AND HAS BEEN ON WORKERS COMPENSATION. THE CUSTOMER HAS MARKED THE CART AS HAVING MISSING SCREWS/BOLTS AND IT IS NO LONGER IN SERVICE. THE CUSTOMER REPORTED THAT, DESPITE GETINGE'S RECOMMENDATION TO REPLACE THE CART, THEY ARE CONSIDERING ENGAGING A THIRD-PARTY SERVICE PROVIDER TO PERFORM REPAIRS.
Additional Manufacturer Narrative
ADDITIONAL INFORMATION WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE INVESTIGATION.NO UDI IS AVAILABLE FOR THE AFFECTED DEVICE, SINCE UDI WAS NOT REQUIRED WHEN THE DEVICE WAS MANUFACTURED IN 2015.