Patient's exact age is unknown; however, it was reported that the patient was over the age of 18.(b)(4).The returned jagtome was analyzed, and a visual evaluation noted that the cutting wire was detached from the active cord insert inside the handle disabling the ability to actuate the device.A functional evaluation could not be performed due to the condition of the device.No other issues with the device were noted.According to the product analysis, the cutting wire was detached from the active cord insert inside the handle.Upon further analysis, the active cord was removed, and the aluminum disc was not present.Based on review and analysis of all available information, the most probable cause of this complaint is manufacturing deficiency.An investigation was opened to address this issue.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.A search of the complaint database confirmed that no similar complaints exist for the specified lot.A labeling review was performed and from the information available, this device was used per the directions for use (dfu)/product label.
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It was reported to boston scientific corporation that a jagtome rx 44 was in the papilla duodeni vateri during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6), 2020.According to the complainant, during the procedure, the cutting wire of the jagtome was unable to bow.The procedure was completed with another of the same device.There were no patient complications reported as a result of this event.The patient's condition following the procedure was reported to be stable.This event has been deemed reportable based on the investigation results: cutting wire detached.
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