As part of a remedial activity, lumenis conducted a retrospective review of all its slimline 200¿ fiber complaint files from january 2015 to may 2017.An investigation of the reported event found that the reported malfunction of the slimline 200¿ fiber was similar to a device malfunction that was alleged to have caused or contributed to a potentially harmful situation.Because the company is aware that this malfunction was alleged to have caused or continued to a serious injury (reference mdr #3004135191-2017-00002), this event represents a reportable malfunction.The fiber was returned to lumenis for product analysis, but analysis failed to indicate a root cause or probable root cause.In an abundance of caution, lumenis is reporting this event as a product problem/malfunction.Although the doctor was able to remove the broken fiber fragments from within the kidney and no patient harm had been reported, lumenis is also reporting this as an adverse event as medical intervention was required to preclude serious injury.
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