Company: Med-El Elektro-Medizinische Gerate GmbH
Product: Combi C40+ and Pulsar cochlear implant systems
Date: 11/16/04
Failure to establish and maintain procedures for analyzing processes, work operations, concessions, quality audit reports, quality records, service records, complaints, returned product, and other sources of quality data to identify existing and potential causes of nonconforming product, or other quality problems. Appropriate statistical methodology shall be employed where necessary to detect recurring quality problems, as required by 21 CFR 820.100(a)(1). For example, there is no procedure addressing the data entry requirements for transferring information from complaint files to the electronic complaint database. The database is used for data analysis. All essential information from complaints and failure analysis information contained within each complaint was not transferred to the electronic complaint database.
Failure to establish and maintain procedures to control product that does not conform to specified requirements. The procedures shall address the identification, documentation, evaluation, segregation, and disposition of nonconforming product. The evaluation of nonconformance shall include a determination of the need for an investigation and notification of the persons or organizations responsible for the nonconformance. The evaluation and any investigation shall be documented, as required by 21 CFR 820.90(a). For example, failure analysis photos show surface contamination of electronic substrates. Even though some contamination was identified as dendrites, other contaminants had not been analyzed. All contaminants could potentially form DC leakage paths. The failure of the cochlear implant can result in pain, uncomfortably loud sound sensation, noise perceptions, etc., but the relationship of these patient perceptions to potential product failure modes is not explained in the failure investigations.
Failure to provide procedures addressing the data entry requirements for transferring information from complaint files to the electronic complaint database. The database is used for data analysis. When all essential information from complaints and failure analysis fails to provide the results of a process, which cannot be fully verified by subsequent inspection and test, the process shall be validated with a high degree of assurance and approved according to established procedures, as required by 21 CFR 820.75. For example, your firm failed to comply with the requirements of the government standard that is reported by used during validation of the ET0 sterilization process. MED-EL stated during the inspection that ET0 validation was conducted according to the British Standard EN550:1994 and performance qualification using B3.4.4 Method C: Half-cycle method (EIR – 3/29- 4/1/04-pg.9 & 10). Review of the firm’s validation test data indicated that the _____ half cycle runs were not performed at the worst case cycle parameter specification of _____ ETO gas (the minimum gas concentration specified). The _____ validation runs were performed with gas concentrations at _____ and _____
Your _____ response, _____ appears to be adequate
Failure to provide all MDR information to FDA, as required by 21 CFR 803.50. For exam pie, review of MDRs for cochlear explants resulting from a loss of hermeticity reported the failure mode as electronically no longer working within specifications. The manufacturer was aware that the root cause of these failures was a “Loss of Hermeticity.” There were over _____ MDR reports attributing device failure to “out of specification” devices, without reporting the root cause of the failure as due to a “Loss of Hermeticity.” Additionally, your firm was aware that many of the “loss of hermeticity” devices showed evidence of _____ and _____, on the _____, which accounts for some of the pain experienced by device users.
Issuer: Center for Devices and Radiological Health (CDRH)
