FDA 483 - Richard Wolf Medical Instruments Corp. - March 18, 2020

Richard Wolf Medical Instruments Corp. in Vernon Hills, IL, received a Form FDA 483 for failing to submit a Medical Device Report (MDR) within the required 30-day timeframe. The firm became aware of a malfunctioning insufflator and TEM pump that delayed a surgery in August 2018 but did not report it to the FDA until March 2019. This indicates a significant delay in reporting a device malfunction that could contribute to serious injury if it were to recur.