InjuryIZZ
MULTIX TOP
Received Jun 17, 2011 · Event occurred May 24, 2011
Report 2240869-2011-00019 · MDR key 2142301
Device
Product problems
- Improper or Incorrect Procedure or Method
Patient
Not reported
- Injury
Narrative
Additional Manufacturer Narrative
THE OPERATOR MANUAL FOR MULTIX TOP SYSTEM (B)(4) CONTAINS CHAPTER ON GENERAL SAFETY AND INFORMS ABOUT RISK OF COLLISION AND POSSIBLE CRUSHING ZONES. IF THE CUSTOMER FOLLOWS THE PROCEDURE, A DEATH OR SERIOUS INJURY IS UNLIKELY. (B)(6).
Description of Event or Problem
IT WAS REPORTED THAT DURING A STUDY ON MULTIX TOP PATIENT'S FINGERTIP GOT INJURED AND REQUIRED FURTHER SURGICAL TREATMENT. ADDITIONALLY, IT WAS REPORTED THAT THE EVENT WAS CAUSED BY THE USER ACCIDENTLY PRESSING ON THE SYSTEM FOOTSWITCH. THE DESCRIBED EVENT OCCURRED IN (B)(6).