This remediation mdr was generated under
(b)(4), as a result of warning letter cms# 617147.The investigation was conducted by the supplier.The investigation concluded that spotting and light output degradation is often a care and maintenance issue, especially if other companies' items are also having the same issue.A failure of the blade light guide would be unlikely.The results reported indicated the event was confirmed.The root cause was determined to be improper care and maintenance.D3, d4 udi, g2, g5 all unknown.
|