It was reported to boston scientific corporation that a spyscope ds ii access & delivery catheter was used in the pancreas during a pancreatic stone crushing procedure performed on (b)(6) 2023.During the procedure, the image of the spyscope ds ii was lost after fifteen minutes of usage.Reportedly, an ehl probe was fired when the visualization problem occurred.The procedure was not completed due to this event and will be rescheduled on (b)(6) 2023.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 spyscope ds ii access & delivery catheter was used in the pancreas during a pancreatic stone crushing procedure performed on (b)(6) 2023.During the procedure, the image of the spyscope ds ii was lost after fifteen minutes of usage.Reportedly, an ehl probe was fired when the visualization problem occurred.The procedure was not completed due to this event and will be rescheduled on (b)(6) 2023.There were no patient complications reported as a result of this event.
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Block d4, h4: the complainant was unable to report the lot number; therefore the manufacture date and expiration date are unknown.Block h6 (impact codes): imdrf impact code f05 is being used to capture the reportable event of delay to treatment/therapy.Block h10: the returned spyscope ds ii was analyzed, and a visual evaluation noted signs of use in the form elevator marks were noted on the shaft of the catheter.Elevator marks were measured from the tip.No damage was noted.Witness marks were observed on the contacts of the umbilicus connector, indicating it was connected to a controller.An image assessment for visualization was performed.The device was plugged into the controller.A live, clear image was displayed.No problems were observed with physical connectivity of the device.The umbilicus connector was visually inspected, and no damage or defects were noted.The device was fully articulated in all directions; no problems were identified with the image.X-ray imaging of the distal tip showed no problems with the redistribution layer (rdl) or thru-silicon vias (tsvs).X-ray imaging of the handle showed no problems with the printed circuit board assembly (pcba) or camera wires.The handle was opened and the components within were visually inspected.It was noted that there was procedural residue on the pofs and camera wire in the breakout region, indicated procedural fluids had flowed back up the optics lumen into the handle during use.The tip was blocked, and saline was flushed through the irrigation tubing to induce backflow of saline into the optics lumen.This caused the image to be disrupted, with blue and orange lines across the screen and a purple hue, leading to a full loss of image.The saline was drained from the optics lumen and the image was restored.The reported event was confirmed.During product analysis, it was noted that procedural residue remained at the top of the optics lumen in the breakout.The optics lumen was filled with saline and the image was disrupted.Draining the optics lumen resulted in the restoration of the image.The image signal does not withstand the change in capacitance created by the introduction of saline into the optics lumen, and procedural factors can cause this fluid to enter the optics lumen during use.An investigation to address this problem has been completed.Based on all gathered information, the probable cause selected for the image failure due to fluid in the optics lumen is cause traced to device design, which indicates that the problems are traced to the design specifications 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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