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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 M00542420
Device Problem Optical Problem (3001)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/22/2023
Event Type  malfunction  
Manufacturer Narrative
Block h6 (device codes): problem code a06 captures the reportable event of loss of visualization inside the patient.
 
Event Description
Note: this report pertains to one of four devices used during the same procedure.Refer to manufacturer report number 3005099803-2023-04901 for the first exalt model d scope 3005099803-2023-04903 for the second exalt model d scope, 3005099803-2023-04904 for the third exalt model d scope, and 3005099803-2023-04900 for exalt model d controller.It was reported that an exalt model d single use duodenoscope was used during an ercp procedure performed on (b)(6) 2023.During the procedure, visualization was lost and the loading screen appeared.The system was restarted but visualization could not be regained.It was reported that three exalt model d scopes malfunctioned during this procedure.The physician swapped scopes and completed the procedure.There were no reported patient complications as a result of this event.No further information has been obtained despite good faith efforts.
 
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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 Key17728707
MDR Text Key323170582
Report Number3005099803-2023-04903
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
Type of Report Initial
Report Date 09/12/2023
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 Model NumberM00542420
Device Catalogue Number42421
Device Lot Number0030780542
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 08/22/2023
Initial Date FDA Received09/12/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/03/2023
Is the Device Single Use? Yes
Type of Device Usage Unknown
Patient Sequence Number1
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