BOSTON SCIENTIFIC CORPORATION EXALT MODEL D SINGLE-USE DUODENOSCOPE; DUODENOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
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Model Number M00542421 |
Device Problem
Optical Problem (3001)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/21/2023 |
Event Type
malfunction
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Manufacturer Narrative
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Block h6: imdrf device code a06 captures the reportable event of loss of visualization inside the patient.
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Event Description
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It was reported to boston scientific corporation that an exalt model d single use duodenoscope was used during an endoscopic retrograde cholangiopancreatography (ercp) to treat choledocholithiasis, on (b)(6) 2023.During the procedure, the physician was using spy scope and exalt model d scope with electrohydraulic lithotripsy (ehl), to remove a large stone.The spy scope was removed from the exalt model d scope to go in and clean the duct out with an extractor pro retrieval balloon.Once the spy scope was removed, the exalt model d scope image was lost.The exalt model d scope loading screen was displayed.Therefore, the physician switched to a reusable scope to complete the procedure.No patient complications were reported as a result of this event.
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Event Description
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It was reported to boston scientific corporation that an exalt model d single use duodenoscope was used during an endoscopic retrograde cholangiopancreatography (ercp) to treat choledocholithiasis, on (b)(6) 2023.During the procedure, the physician was using spy scope and exalt model d scope with electrohydraulic lithotripsy (ehl), to remove a large stone.The spy scope was removed from the exalt model d scope to go in and clean the duct out with an extractor pro retrieval balloon.Once the spy scope was removed, the exalt model d scope image was lost.The exalt model d scope loading screen was displayed.Therefore, the physician switched to a reusable scope to complete the procedure.No patient complications were reported as a result of this event.
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Manufacturer Narrative
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Block h6: imdrf device code a06 captures the reportable event of loss of visualization inside the patient.Block h10: the returned exalt model d single use duodenoscope was analyzed, passed all tests performed, and exhibited normal device characteristics.A visual inspection of the returned device revealed no evidence of damage on the shaft or tip of the device.No fogging or condensation was noted on or in the lens.Witness marks were observed on the pads of the umbilicus connector, indicating it was connected to a controller.The device imaging was tested by plugging the umbilicus connector into a controller, and a live image was displayed, and the light-emitting diode (led) turned on.No issues against the image or lightning were observed.Articulation of the tip was performed using the control knobs on the handle, and no changes to the image quality were observed.The tip was manually manipulated, and no issues were observed with the image.Manipulation of the umbilicus connector did not prompt any failure with the image or lighting.A non-complaint spyscope ds ii device was plugged into its controller to turn it on, and the scope was passed into the returned exalt model d scope biopsy port and through the working channel until it exited the distal end.The spyscope ds ii was removed from the working channel; no exalt image issues were observed during this testing.The handle was opened to visually inspect the repeater button printed circuit board (pcba) at the top of the handle; no visual defects were identified.The umbilicus connector was opened to visually inspect the electronic components inside; no issues were identified.With all the available information, boston scientific corporation could not confirm the reported event.As product analysis was unable to replicate the reported issue or identify any problem that could have caused or contributed to the reported event.The conclusion code selected for this event is no problem detected.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 directions for use (dfu) / product label.
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