FDA Cites California Devicemaker for Not Investigating Failures

Channel Medsystems’ Emeryville, California failed to properly investigate malfunctions in an ablation device to find the source of the problems, FDA investigators found during an inspection.

The firm identified multiple Cerene cryotherapy devices — an endometrial ablation device used to lessen heavy menstrual bleeding — that failed to meet performance specifications, according to the FDA’s inspection report.

The company failed to identify the root causes of the failures, including a nonworking power switch, an inadequate connection that prevented the device from providing treatment, and delayed venting of nitrous oxide, according to the Form 483 report.