Based on the information provided by the complainant, the tissue samples involved in this event were derived from the "6 hour cycle" protocol comprising 63 cassettes, which started in retort b at 18:45pm on 04 october 2019 and completed at 07:30am on (b)(6) 2019.The user response to the information detailed in association with the "1337" error code was not appropriate, which is not to use the instrument and to contact service.No other use error(s) was identified in the instrument logs in relation to the interaction between the user and the instrument either prior to, during execution of the "6 hour cycle" started in retort b at 18:45pm on 04 october 2019, from which sub-optimal tissue processing was reported.Investigation of this complaint found that the instrument functioned as designed during execution of the "6 hour cycle" protocol started in retort b at 18:45pm on 04 october 2019.The root cause of the sub-optimal tissue processing reported by the complainant is the use of formalin contaminated wax for the wax infiltration step of the protocol.The root cause of the wax contamination with formalin was failure of the user to follow the information displayed on the instrument monitor, which is not to use the instrument and to contact service, when the "1337" error which indicates a leaking retort wax valve occurred.The root cause of the "1337" error generated is a leaking retort b into the wax line due to a piece of string found in the retort b wax valve.
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The leica tac supervisor received a complaint detailing the following: "bad processing, wax valve leak error.Dry poorly fixed tissue on the periphery of the tissue.The lab staff have noted dry tissue and some difficulty sectioning.Wax found in ethanol and formalin bottles." on 22 october 2019, a leica field service engineer (fse) visited the customer site in order to assess the operation and function of the instrument.The fse performed visual inspection of the instrument and documented the following: "check wax content in wax chamber 1 to 4 found wax in wax chamber 3 (85%) and 4 (97%) is dirty, there is debris floating.Check reagent content bottle 1 to 16, found content in bottle 6 ethanol 96% should look clean and clear but it is milky, dirty, and slimy.Dismantle retort b wax valve found a piece of string blocking wax valve from closing properly which is the root cause for error 1337 retort wax valve leaking.Do not use instrument; contact service, retort b.Retort a wax valve, no debris found".On 22 october 2019, the leica product application specialist received information that all cases involved in this event were diagnosable.
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