Liposuction Device Maker Receives FDA Warning Over MDR Procedures
Belgium-based Euromi has been hit with a far-ranging FDA warning letter that chides the company for not properly handling complaints, including cases of cannula tips from a liposuction system breaking and lodging in patients.
During a Jan. 12 to 15 inspection of Euromi’s Verviers, Belgium, facility, an FDA investigator determined the company had failed to establish procedures to ensure that complaints related to the EVA Sp liposuction system are analyzed in a timely manner.
The company also neglected to document oral complaints upon receipt, ensure that complaint investigation records contained all required information, explain why some complaints weren’t investigated and ascertain whether complaints were evaluated for MDR reportability. That final citation extended to events in which cannulae broke and fragments remained in the patient.
Euromi also failed to establish internal systems for the timely transmission of complete MDRs, including instructions for obtaining and completing a Form 3500A.
The investigator further dinged the devicemaker for not establishing procedures to ensure that all received products conform to specified requirements. For example, Euromi didn’t ensure that its contract sterilizer validated the sterilization of a disposable tubing set used with the EVA Sp6 liposuction device.
Another citation notes the firm’s corrective and preventive actions procedure doesn’t include requirements for analyzing data to determine existing and potential causes of nonconforming product or other quality problems.
“The CAPA file for nonconformance 108 (for bending problems on 2.0 mm and 2.5 mm infiltration cannulas) did not identify the batch records of the device used for testing,” the warning letter says. Euromi also failed to verify and validate the effectiveness of its corrective actions.
The firm was also cited for failing to ensure that all inspection, measuring and testing equipment is suitable for the intended purposes. For example, the tester used to analyze cannula flow contained measuring devices that hadn’t been calibrated to ensure the equipment is capable of producing valid results.
The FDA also took the company to task for not having proper control measures in place to ensure that outdated documents are removed and not unintentionally used. Euromi also failed to obtain approval dates and signatures to ensure documents were removed.