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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 11/04/2021
Event Type  malfunction  
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 on (b)(6) 2021.During the procedure, the physician was using an exalt scope and the image was lost, only blue screen could be seen.They checked all connections but were unable to restore the image.They switched to a reusable scope to complete the procedure.There were no patient complications as a result of this event.
 
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.
 
Manufacturer Narrative
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.Witness marks were observed on the pads of the umbilicus connector.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 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 problems were observed with the image.The umbilicus was manipulated by rotating the connector at the controller, applying tension to the cable and stressing the strain relief at the connector and the handle; no problems were observed with the image.The reported event was not confirmed.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 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 on (b)(6) 2021.During the procedure, the physician was using an exalt scope and the image was lost, only blue screen could be seen.They checked all connections but were unable to restore the image.They switched to a reusable scope to complete the procedure.There were no patient complications 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
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
2546 calle primera
alajuela
CS  
Manufacturer Contact
carole morley
300 boston scientific way
marlborough, MA 01752
5086834015
MDR Report Key12887867
MDR Text Key286124811
Report Number3005099803-2021-06067
Device Sequence Number1
Product Code FDT
UDI-Device Identifier08714729993605
UDI-Public08714729993605
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K193202
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 12/29/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/29/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date12/08/2022
Device Model NumberM00542421
Device Catalogue Number42421
Device Lot Number0026484867
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/22/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/02/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/08/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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