It was reported to boston scientific corporation that a captivator round stiff snare was prepared for use during a procedure performed on (b)(6) 2023.During preparation when the device was tested, it was noted that there was an active cord connector connection problem.Upon inspection, the cautery pin was detached/broken.The procedure was completed with another captivator snare.There were no patient complications reported as a result of this event.
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It was reported to boston scientific corporation that a captivator round stiff snare was prepared for use during a procedure performed on (b)(6) 2023.During preparation when the device was tested, it was noted that there was an active cord connector connection problem.Upon inspection, the cautery pin was detached/broken.The procedure was completed with another captivator snare.There were no patient complications reported as a result of this event.
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Block h6: medical device code a0501 captures the reportable event of cautery pin detached.Block h10 investigation results: a captivator round stiff snare was received for analysis.Visual and microscopic analysis of the returned device revealed that one measure of the 2 in 1 pin was out of specification.During the product analysis, the device was connected with three different cables.The bsi cable had connected well, the device was plugged with non-bsi active cord (conmed and erbe) and the cable also connected; however, no strong force was needed to remove it.Additionally, the 2-1 connector is correctly attached.No other problems were noted.The reported complaint of cautery pin detachment of device or device component could not be confirmed since the 2-1 connector was correctly attached.Based on the information available and the device analysis performed, it was noted that one dimension was not according to the 2 in 1 drawing, therefore, the most probable root cause for the reported complaint is manufacturing deficiency.Capa-00007233 was opened to investigate the issue between the interaction with 2 in 1 connector and the active cord, and issues reported in multiple devices.
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