Company: ConMed Corp.
Product: Hyfrecator 2000 and other electrosurgical devices and accessories
Date: 05/08/2003

Failure to validate computer software for its intended use according to an established protocol prior to approval and issuance, and document the results of these validation activities, as required by 21 CFR 820.70(i). For example, a software program used to run load curves has not been validated to demonstrate data integrity from the initial point of collection. These load curves were used in design verification activities to assure that design input specifications for power out versus load resistance were met.

FDA District: Denver District Office