We were most concerned to learn of the issue with the Fiber Optic Laryngoscope blade at the Hospital for Sick Children in Toronto. Both Mr. Matthews and Dr. Luginbuehl were very helpful in bringing the information to our attention and coordinating matters to ensure proper findings.

It is important to note that the blade was sent to us for further examination. We tested the blade completely and examined it completely through a high-power microscope. We were not able to determine exactly why the blade tip became separated; however, we believe that there may not have been sufficient soldering to hold the tip in place if the blade were to receive a shock of some kind. We can only speculate due to the fact that soldering matter could have fallen out after the tip separated.

It is important to note that Heine Optotechnik (Herrsching, Germany) has been manufacturing this product since 1983. Since that time, we have manufactured several million units. This is the first and only reported incident worldwide. We have investigated whether any possible claim was registered with the Federal Drug Administration, Health Canada, and European authorities. None was found.

Although our blades are single-piece blades, meaning that there is no disassembly possible, the blades actually have 12 parts. As with most products, this one has several components that come together to form the whole. Heine has never claimed otherwise.

We see this incident as isolated and have taken additional precautions to verify all current inventories. Further, we are placing specific emphasis on this part of the manufacturing process to ensure this incident does not repeat itself.

It is important to note that Heine manufactures all products to the highest International Organization for Standardization Quality Standards. Our commitment is to manufacture the best products in class in the marketplaces we serve.

Heine USA Ltd., Dover, New Hampshire. www.heine.com