A medical device manufacturer in Yokneam, Israel failed to submit adverse event reports to the FDA within 30 days after becoming aware of numerous complaints that warranted them, the agency said.
According to a Form 483, FDA investigators who inspected the Lumenis facility from Jan. 30 to Feb. 2 observed that at least nine customer complaints should have been reported as MDRs.
These included complaints for patient burns caused by the firm’s LightSheer Desire device; first and second degree burns caused by its LightSheer Duet device; and a patient extended surgery, stiches and open wound caused by a malfunction of its VersaCut+ Tissue Morcellator system.
Several months went by from the time that Lumenis became aware of these adverse events to when these were reported.
There was also a complaint from a patient who lost hair after receiving acne treatment with the M22 Acne Filter that the firm did not report as an MDR. Instead, it initiated a recall of the filters in November 2015, though the FDA wasn’t made aware of that until April 2016.
In addition, the company’s MDR procedure includes a requirement for maintaining a list of product malfunctions, but “management acknowledged that the list did not exist,” the agency said.
Out of the 12 identified nonconformities, four were related to the firm’s design procedures. For example, Lumenis failed to adequately document design validation results for its VersaCut+ device, and to revisit the design plans “as the design and development milestones and the responsibilities for implementation evolved,” the investigators wrote.
The firm’s procedures for CAPA actions, accepting incoming products, conducting quality audits, and identifying products during all of their lifecycle stages, as well as one of its approved process validation were also flagged as inadequate.