Report source: (b)(6) clinical study.(b)(4).The device has been received for analysis; however, the analysis has not yet been completed.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
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It was reported to boston scientific corporation that an exalt model d single-use duodenoscope was introduced for use in an endoscopic retrograde cholangiopancreatography (ercp) on (b)(6), 2022.The patient was placed under general anesthesia in the prone position at the start of the procedure.Approximately one minute after the exalt scope was inserted, the image from the scope froze and an error screen appeared.The scope was removed from the patient and the procedure was completed with a reusable scope.There were no patient complications reported as a result of this event.
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Block g2 (report source): e7156 exalt dscope 02 clinical study block h6 (device codes): problem code a06 captures the reportable event of loss of visualization inside the patient.Block h10: the returned exalt model d single use duodenoscope was visually inspected.No evidence of any damage or defect was observed on the shaft or tip of the device.No fogging or condensation was noted on or in the lens.No issues with the device handle were noted.No damage to the umbilicus cable, connector, or its ports were observed.An image assessment was performed by connecting the device to an exalt controller; a live, clear image was displayed.The scope was articulated in all directions.The image was lost and the scope error screen appeared when the scope was articulated fully in the up position.To determine if issues with the light-emitting diode (led) signal contributed to image loss, the scope was unplugged and re-plugged into the controller, the led was turned off from the controller, and the scope was then articulated up.Image was lost again, indicating the issue was unrelated to led function.Electrical testing of the device with a digital multimeter was performed and found continuous connections through the umbilicus connector and cable.Electrical components in the distal tip were visualized under real-time x-ray to identify potential damage.At approximately 10mm proximal to the distal cap, a kinked cable and potential damage was observed under x-ray.The camera cable was removed from the scope and the distal end was stripped to access the wires.The twin-ax camera cable was kinked, and potential damage to the external braid or low voltage differential signaling wires (lvds) within was observed under x-ray imaging.The twin-ax wire was stripped and the lvds wires inside were accessed.Necked wire coating indicated damage to the red lvds wire.The internal wire had likely broken and the component became further damaged during analysis.The reported event was confirmed.Therefore, based on the investigation findings, the probable cause for the reported event was determined to be manufacturing deficiency, which indicates that the failure mode is attributable to the manufacturing process.An investigation to address this problem is in progress.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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