Block b3: approximated based on the date the manufacturer became aware of the event.Block h6: problem code a090402 captures the reportable event of snare unable to deliver energy.Problem code a050702 captures the reportable event of snare loop cutting problems.Block h10: investigation results a captivator medium hexagonal stiff snare was received for analysis.Visual inspection of the returned device revealed no problems were found.Microscope inspection noted some marks of friction on the 2 in1 connector, probably by the interaction with the active cord.Functional testing was performed, and the loop could extend and retract well.The device was tested with a boston scientific active cord and the device connected well.Additionally, the device was plugged in with a non-bsc active cord, however, the device connected well.Finally, the device was plugged in with another non-bsc active cord and the device connected well.During dimensional testing it was noted that the internal gap dimension of the 2 in 1 connector was not according to the referenced drawing.Electrical testing was performed, and the device was found within specification.No other problems were noted.The reported complaint of device failure to deliver energy was unable to be confirmed since the device passed electrical testing upon return.In addition, the 2 in 1 connector had some marks of friction probably by the same force applied to attach the handle to the active cord.The reported complaint of loop failure to cut was not confirmed since the device cannot be functionally evaluated with respect to anatomical/procedural factors encountered during the procedure.The reported event of device interaction with another device was confirmed.During dimensional analysis it was noted that some measurements of the 2 in 1 connector were not as expected.An investigation to address this problem is in progress.Based on the analysis of the returned device and the information available, the most probable cause is manufacturing deficiency.
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