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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EXALT MODEL D SINGLE-USE DUODENOSCOPE; DUODENOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
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BOSTON SCIENTIFIC CORPORATION EXALT MODEL D SINGLE-USE DUODENOSCOPE; DUODENOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID Back to Search Results
Model Number M00542421
Device Problem Optical Problem (3001)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/18/2021
Event Type  malfunction  
Manufacturer Narrative
(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.
 
Event Description
It was reported to boston scientific corporation that an exalt model d single-use duodenoscope was used during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed in the duodenum on (b)(6) 2021.During the procedure, when the physician was articulating the scope, the screen went to 4 gray dots and then to the ercp scope error screen.The procedure was completed with another exalt model d single-use duodenoscope.There were no patient complications reported as a result of this event.
 
Manufacturer Narrative
Block h6 (device codes): problem code a06 captures the reportable event of loss of visualization inside the patient.The returned exalt model d single-use duodenoscope was analyzed, and a visual evaluation noted that there was no evidence of any damage or defect on the shaft or tip of the device.No fogging or condensation was noted on or in the lens.An image assessment was performed by connecting the device to an exalt controller.Upon connection, a live image was displayed.No problems were observed with the image.Articulation of the scope was performed using the control knobs on the handle, and the image became disrupted when the tip was articulated in the "right" direction.The 5-dot reconnection screen would display, and then the scope error screen.The unit was disconnected, the tip was straightened, and the device was reconnected to the controller; a live image was displayed until the scope was articulated in the "right" direction.The scope error screen could be avoided, and the camera image reconnected, if the scope was articulated back into a straight orientation while the 5-dot screen was still showing.X-ray inspection of the wiring in the distal tip was conducted.A region of kinked camera wires was observed, with potential damage to the conductors.The tip of the device was removed and the distal end of the camera wires were exposed.Kinking of the overall camera bundle was observed.The protective wrap was removed and epoxy was observed to have wicked from the camera printed circuit board assembly (pcba), proximally along the camera wires.The damaged twin-ax camera cable was isolated and stripped to expose the interior conductors.Kinks in the twin-ax conductors were observed.X-rays at this location confirmed a break in the white cable.The reported event was confirmed.An investigation is in place to address this problem.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.
 
Event Description
It was reported to boston scientific corporation that an exalt model d single-use duodenoscope was used during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed in the duodenum on (b)(6) 2021.During the procedure, when the physician was articulating the scope, the screen went to 4 gray dots and then to the ercp scope error screen.The procedure was completed with another exalt model d single-use duodenoscope.There were no patient complications reported as a result of this event.
 
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Brand Name
EXALT MODEL D SINGLE-USE DUODENOSCOPE
Type of Device
DUODENOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
MDR Report Key12001452
MDR Text Key256271284
Report Number3005099803-2021-02517
Device Sequence Number1
Product Code FDT
UDI-Device Identifier08714729993605
UDI-Public08714729993605
Combination Product (y/n)N
PMA/PMN Number
K193202
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 07/20/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date02/11/2022
Device Model NumberM00542421
Device Catalogue Number42421
Device Lot Number0025715136
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/08/2021
Initial Date Manufacturer Received 05/19/2021
Initial Date FDA Received06/15/2021
Supplement Dates Manufacturer Received06/28/2021
Supplement Dates FDA Received07/20/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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