MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EXALT MODEL D SINGLE-USE DUODENOSCOPE; DUODENOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID

Model Number M00542421

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Optical Problem (3001)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/10/2023

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 on (b)(6) 2023, for biliary stent removal and sweep of the bile duct to treat choledocholithiasis.During the ercp procedure, the scope's light-emitting diode (led) was cutting in and out.The physician continued with the procedure.However, a few minutes later the image was lost, and the scope error message was displayed.A second exalt model d scope was used to complete the procedure without patient complications.

Manufacturer Narrative

Block h6: device code a06 captures the reportable event of loss of visualization inside the patient.

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 on (b)(6) 2023, for biliary stent removal and sweep of the bile duct to treat choledocholithiasis.During the ercp procedure, the scope's light-emitting diode (led) was cutting in and out.The physician continued with the procedure.However, a few minutes later the image was lost, and the scope error message was displayed.A second exalt model d scope was used to complete the procedure without patient complications.

Manufacturer Narrative

Block h6: 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 was visually inspected.No evidence of any damage or defect was observed on the shaft or tip of the device.No fogging, condensation, or residue 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.An image assessment was performed by connecting the device to an exalt controller.Upon connection, a live, clear image displayed.The umbilicus plug was manipulated by gently rocking it at its connection with the controller socket.The image was lost.During these manipulations the exalt loading screen was displayed.The image occasionally returned, occasionally displayed the scope-error screen, and occasionally displayed the exalt boot screen, despite similar manipulation taking place.A live image was retained, and the scope was unplugged from the controller and plugged into a second controller.Similar manipulation of the plug was performed; image loss could be replicated, however, not as frequently as the first controller.The handle was opened, and the repeater button printed circuit board assembly (pcba) was inspected, no visual defects were identified.The umbilicus connector was visualized under real-time x-ray, and no issues were detected.The umbilicus connector was opened to inspect the internal connections, no damage or defects in the connector was observed.During returned product analysis, an image was displayed during initial testing.However, the exalt model d scope was tested in two controllers and the image could be lost by manipulating the plug in the controller.An additional test was performed by plugging the scope into the original testing controller and the image loss was forced.The scope was unplugged and tested for continuity at the umbilicus pads using a calibrated digital multimeter (dmm) in continuity mode.The light emitting diode (led) and serial clock (scl) signals were not as expected during initial testing.Although image issues were identified during initial testing, the issues could not be replicated after re-testing for scope image, and no physical electrical issues were found via inspection and x-ray.Additionally, at the end of testing, manipulation of the scope could not replicate image loss.Problems with the returned device were traced to an intermittent connection issue at the umbilicus pcba, likely contributing to the issues observed by the user and during initial investigation testing.Further isolation of the failure could not be performed.Therefore, the probable cause of the reported event was determined to be cause traced to component failure, which indicates that the issues could be traced to an expected or random failure of a component with no detected element of design or manufacturing.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 instructions for use (ifu) / product label.

• 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 Key: 16837533
• MDR Text Key: 314269536
• Report Number: 3005099803-2023-02290
• Device Sequence Number: 1
• Product Code: FDT
• UDI-Device Identifier: 08714729993605
• UDI-Public: 08714729993605
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K193202
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00542421
• Device Catalogue Number: 42421
• Device Lot Number: 0030598867
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/24/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 44 YR
• Patient Sex: Female