Block h6: imdrf device code a050702 captures the reportable event of snare loop cutting problems.Block h10: investigation results a captivator snare was received for analysis.Visual inspection of the returned device revealed no problems.Functional inspection was performed and when the device was connected to the 10-inch loop fixture, the loop could extend and retract well.Electrical testing was performed, and the device was found within specification.No other problems were noted.The reported complaint of loop failure to cut was unable to be confirmed since the device was returned without any failure on it, and after a functional test, the loop could extend and retract properly, and its electrical resistance was found within specifications.In addition, since the device cannot be functionally tested by emulating the anatomical/procedural factors encountered during the procedure the reported allegation cannot be confirmed.Based on the information available and the returned device analysis, the most probable root cause for the reported complaint is no problem detected.
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