Inspection Detail

Inspection: 305355349 - Medtronic Inc

Inspection Information - Office: Santa Ana District Office

Investigation Summary

On December 2, 2004, Employee #1 was operating a Leica Microsystems, microtome machine, Model Number 2155, Serial Number 050231619. Her employer manufactures human heart valves and other related heart repair products. The microtome machine slices tissue samples that are embedded in a paraffin block, similar to a punch press, which then allows the samples to be viewed under a microscope. An adjustable knife is located on a stationary fixture below a specimen-holder clamp and moves up and down like a ram on a punch press. The stroke length of the knife is approximately 2.75 inches. The clamp holds the paraffin block and moves horizontally outwards in very small increments for each new slice, while cycling up and down. During each cycle the chuck scrapes the paraffin block against the fixed knife mounted horizontally at the base of the machine. As Employee #1 was setting up a paraffin block in the specimen-holder clamp, she inadvertently activated the machine through a foot pedal. Her left hand came into contact with the knife and the tips of her thumb and index finger on that hand were amputated. Employee #1 was hospitalized and treated for her injury, which included bone loss. The employer later modified the machine to operate through a hand control.

Keywords: KNIFE, AMPUTATED, SLICER, FINGER, FOOT CONTROL, MACHINE OPERATOR, CAUGHT BETWEEN, FOOT-POWERED PRESS, PUNCH PRESS, PUNCTURE