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 the manufacturer for testing and examination.A lumenis quality engineer examined the fiber and concluded that the "fiber was broken due to excessive bending or exceeding the fiber tensile strength during use.Visually, the fiber appears pinched or twisted which would cause the break".Most probable root cause for this event was determined to be a "use error" although the doctor was able to remove the broken fiber fragments from within the patient 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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