(b)(4).The returned autotome rx 49 was analyzed, and a visual evaluation noted that the cutting wire was broken from the proximal pierced hole, kinked, and blackened.This was consistent with the findings when the device was observed under magnification.No other problems with the device were noted.The product analysis revealed that the cutting wire was broken, kinked, and blackened.The reported failure of failure to bow was confirmed since the cutting wire broke, and this condition inhibits the correct performance of the device and the capability of the device to perform a proper bow.These conditions could have been generated if there was contact between the device and the scope during energization or if the device exceeded the maximum of voltage during procedure.Also, energizing the device prior to performing sphincterotomy can compromise the cutting wire's integrity, which can cause a premature cutting wire fatigue, causing it to break.Additionally, kinking/bending the cutting wire can lead to a break.It is most likely that procedural or anatomical factors encountered during the use of the device could have affected the device performance and its integrity.Based on all gathered information, the most probable root cause of this complaint is adverse event related to procedure.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.A labeling review was performed and, from the information available, this device was used per the instructions for use (ifu) / product label.
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