On (b)(6) 2014, facility contacted richard wolf medical instruments corporation (rwmic) incidating they would like to send in their working element to be checked, routine maintenance.One facility received cost estimate of repairs, facility mentioned an incident where a spark occurred.A few parts on device were replaced due to being loose and/or work out.
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An investigation was completed as the actual device was returned on (b)(4) 2014.A few parts on device were replaced due to being loose and/or worn out.No record of any routine maintenance or repairs.If moisture or liquid were to get in lock hosing, a spark may occur.(i.E.Device not completely dried after reprocessing or from fluids during use due to worn o-ring).Labeling was reviewed and found to be adequate.I.E., intended use, indications and field of use, preparation and cautions.Richard wolf considers this matter closed.However, in the event we receive additional info, we will provide fda with follow-up info.
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