Since lumenis cannot rule out that the fiber tip had broken off in the patient's anatomy, in an abundance of caution lumenis is reporting this event.A search of the complaint database revealed that no other complaints exist for the specified lot.A review of system risk files revealed the following three risks of fibers breaking inside body: risk #1 (1003791_g - risk # 8.1.1) triggered by "user damages fiber external surface during operation" has the potential to lead to prolonged procedure, equipment damage, patient/user/staff injury.Risk #2 (1003791_g - risk # 8.2.1) triggered by "fiber is damaged during shipment" has the potential to lead to prolonged procedure, equipment damage, patient/user/staff injury.Risk #3 (1003791_g - risk # 8.3.1) triggered by "user error (e.G.Excess energy) causes mechanical damage to fiber" has the potential to lead to prolonged procedure, equipment damage, patient/user/staff injury.In each of the "forementioned", the risk has been quantified and found to be negligibly small, and the risk has been characterized and documented as acceptable within full risk assessment.No corrective action or remedial actions were deemed necessary.No injury occurred in this case and the patient was reported "to be fine".The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
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