Block h6: problem code a0501 captures the reportable event of brush detached.Block h10: investigation results an rx cytology brush was received for analysis, and a visual inspection of the returned device revealed the handle returned disassembled as the blue knob was unscrewed.In addition, the working length was bent, and the brush was used based on residue noted.Microscope inspection of the returned device revealed that the tip of the brush was in good condition.No other problems were noted the reported event of brush detached was not confirmed because the results of the analysis performed showed that the brush was in good condition.Most likely procedural factors as handling of the device, the technique used by the physician during initial use, set-up, or shortly thereafter could have affected its condition and caused the working length kink and handle disassembly.Based on the information available and the returned device analysis, the most probable root cause for the reported complaint is no problem detected and the most probable root cause for the failures found during analysis (working length - bent/kinked) is adverse event related to procedure.
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