(b)(4).One (1) 004411100 greenspec fiber optic handle, medium, was received for investigation.Upon receipt the handle was visual examined for any signs of abuse/misuse/damage.Further inspection inside the light chamber of the handle has uncovered a missing insulator which could contribute to the handle heating.The ifu for this product states, "the batteries and bulb chamber in greenspec, snap-light, and emerald must be removed prior to cleaning/disinfection/sterilization." the bulb chamber incorporates two green insulators.One insulator is located near the bulb itself, recessed in the bulb chamber, the other insulator is press fitted into a more conspicuous location on the bottom of the bulb chamber.These easily seen insulators serve two purposes.First, they are electrical insulators preventing a grounding or "shorting" condition as the battery current travels from the battery casing to the bulb itself.And secondly, they serve as "guides" for the electrical pin connector.The bottom insulator fits against the cap of the battery and guides the contact pin which makes contact directly on top of the battery.If that insulator is missing the contact pin could make contact with the body of the handle which in turn would create a "short" condition.The short condition would drain the battery current to the metal housing causing it to heat to hazardous temperatures.Age can be a factor in the insulator deterioration and eventual destruction, and so can frequent and incorrectly administered sterilization and disi nfection processes.Once the insulator material begins to break down it does not take long for it to disintegrate.While a definitive root cause cannot be assigned to the insulator deterioration, the missing insulator is the catalyst for the handle heating.The co mplaint has been confirmed, but a definitive root cause cannot be assigned.
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